Edwards Lifesciences
Apr 18, 2018
Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines. **Key Responsibilities:** + Use a broad range of higher tools and equipment to complete assembly of medical devices precisely and in a timely fashion at each multiple work stations, - advanced proficiency in specified operations - following work order instructions and drawings, using computers to navigate drawings, and entering parts status data. Inventory reconciliation at start of day and when transitioning to next work order. + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter data into manufacturing data systems. + Provide coaching and training to lower level employees, monitor the line performance, evaluate and demonstrate correct approach on work of other employees, in the absence of the Lead + May perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build. + Self-assessment of work, which may include visual inspection under magnification, and sequential review of colleagues work, providing constructive team feedback, including escalating work issues and changes in equipment performance to supervisor for assessment and correction. + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period + Other incidental duties: General work area housekeeping #LI-JE1 Qualifications: **Experience and Qualifications** + H.S. Diploma or equivalent required + 4 years of previous/related experience required + Previous medical device assembly experience preferred **Additional Skills:** + Excellent communication skills + Able to read, comprehend and speak English, and elementary-level understanding of numerical functions + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures + Must be able to work with minimum supervision by following detailed manufacturing instructions + Work in a Team environment, primarily work with colleagues and supervisor + Ability to effectively provide and accept feedback from colleagues based on sequential work reviews and follow up with colleagues to ensure understanding + Flexibility to work overtime to ensure smooth and continuous manufacturing processes + Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Sr. Assembler - Transcatheter Heart Valve Location: USA-USA-Utah - Draper Job Number: 013678
Edwards Lifesciences Draper, UT, USA
Apr 18, 2018
This is a fantastic opportunity to join the Critical Care group, focused on advancing technologies and improve the quality and efficiency of care. With over 40 years of technological advances, Edwards Critical Care group continues to evolve to less-invasive, and non-invasive devices; refine hemodynamic monitoring platforms; and provides evidence-based programs to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Our therapies and products such as the Swan-Ganz and Fogarty catheters continue this high standard used in millions of procedures worldwide. The Associate Specialist, Inside Sales will provide guidance to customers on the use of CC devices resulting in achievement of sales objectives. This position is based out of Irvine, CA. **Job Functions:** + Provide basic guidance (e.g., designated products) to customers on the use of devices and/or products resulting in achievement of sales objectives through generating cold calls to select customers for product lines (e.g., legacy CC products) + Recommend, analyze, and propose basic pricing on existing products by utilizing account history and situational/sales data to drive sales. + Create forecast opportunities and document follow-up all activities in Customer Relationship Management (CRM) Systems + Create ad hoc sales reports to develop proposals and provide to stakeholders (e.g., Manufacturing, Marketing, Electronic Operations) + Other incidental duties assigned by Leadership + Travel up to 25% (National and Regional Sales Meetings in the Continental US) #LI-MO1 Qualifications: **Required Education/Skills/Experience:** + Bachelor's Degree in related field required + 1 year of previous related experience required + Experience in selling, promoting and/or presenting (in written and oral form) medical products + Good problem-solving and critical thinking skills with the ability to learn complex products through independent learning + Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint + Experience in a Customer Relationship Management (CRM) system; Salesforce.com preferred + Good written and verbal communication skills + Good knowledge and understanding of relevant medical products + Good knowledge and understanding of complex computer systems, review target accounts, customize offers, cultivate leads, order/sample product and document activities. + Ability to manage competing priorities in a fast paced environment + Strict attention to detail + Must be able to work in a team environment, including immediate supervisor and other team members in the section or group + Ability to build stable working relationships internally About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Inside Sales, Associate Specialist – Critical Care Location: USA-USA-California - Irvine Job Number: 013673
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
**Role Purpose:** This role as Administrator will provide support to the organization through the customization and configuration of various business systems including Salesforce platform. The position will manage databases and reporting and provide training and support to users. Additionally, the Administrator will provide support to the sales and other teams and coordinate related projects as assigned. This position will take place at Edwards office in Prague, Czech Republic. **Job Functions:** + Create and Manage Changes to the "Salesforce" System + Create and Manage Changes to the different systems + Maintain System, Security and Integrity + User Assistance, Training, Adoption and Satisfaction + Process Creation, Documentation and Maintenance + Data Quality, Migration and Maintenance + Report and Dashboard Creation and Maintenance + Works with stakeholders in enhancements and other projects. Other duties as assigned by Leadership #LI-LZ1 Qualifications: **Required Education/Skills/Experience:** + Have a degree in Information Systems, Economics, Accounting, Logistics or Engineering + Overall 1 Yrs. of technical experience. + Create and Manage Changes to the “Salesforce” and other business systems + Handle on-going customization/ alteration of Salesforce.com. + Maintain, enhance and create workflows, functions and configurations within the business systems environment. + Maintain System, Security and Integrity of systems + Map salesforce.com hierarchy and territories in response to personnel changes. + Reassign Accounts, Contacts, and Opportunities in response to personnel changes. + Grant/ remove and maintain user licenses. + Maintain security including sharing rules and security levels. + Design, Create and maintain user roles, profiles and hierarchies. + Monitor application storage usage and archive data as needed. + Create and administer training to existing or new users/groups. + Create new reporting capabilities and respond to ad hoc reporting requests as needed. + Fluent spoken and good written English required, another International language is advantage. + Collaborate and work closely with internal and external team members in an agile work environment + Strong problem solving skills and decision making ability. + Ability to learn and apply technical information in a fast-paced, demanding work environment. + Ability to follow policies and procedures; attention to detail. + Possess and display sound judgment; initiative; flexibility and detail-orientation. #LI-LZ1 About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Associate Analyst, Business Systems Location: Europe, Middle East, Africa, Canada (EMEAC)-Czech Republic Job Number: 013638
Edwards Lifesciences Czech Colony, Sanath Nagar, Hyderabad, Telangana, India
Apr 18, 2018
**Role Purpose:** The purpose of this role is to provide tier 1 IT Support in Edwards Lifesciences Global IT Service Desk and to mentor/provide training to Junior Analysts **Job Functions:** Essential Job Functions + Respond as a SPOC to requests for technical assistance of internal user and contractors via phone and electronically (email, self-service portal). + Log issue in a tracking system and escalate to tier 2 support groups, if more specialized assistance is needed. + Prioritization and Queue management + Identify and escalate situation requiring urgent attention + Interact with users and co-workers (local & remote) to support identification and resolution of problems + Work as a point of reference for peers and support them resolving difficult/unknown technical issues. + Mentoring and providing training to Junior Analysts in the team Marginal Job Functions + Contribution to Knowledge Base + Involvement in team projects and quality. #LI-LZ1 Qualifications: **Required Education/Skills/Experience:** + IT background or at least 2 year experience in a Service Desk/Technical role + Proficiency in English. + Advanced knowledge of any other European language is a plus but not a requirement. + Strong analytical skills + Strong technical skills at Analyst level are required + Exceptional interpersonal and communication skills with high level of professionalism and strong customer orientation attitude. + Team player with a positive attitude. + ITIL Knowledge is highly appreciated + Microsoft Office and Windows operating system literacy is required, Windows 10 Knowledge is required + Mobile device support experience is a plus #LI-LZ1 About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Senior Global Service Desk Analyst Location: Europe, Middle East, Africa, Canada (EMEAC)-Czech Republic Job Number: 013641
Edwards Lifesciences Czech Colony, Sanath Nagar, Hyderabad, Telangana, India
Apr 18, 2018
**Role Purpose:** The purpose of this role is to provide tier 1 IT Support in Edwards Lifesciences Global IT Service Desk. **Job Functions:** + Respond as a SPOC to requests for technical assistance of internal user and contractors via phone and electronically (email, self-service portal). + Log issue in a tracking system and escalate to tier 2 support groups, if more specialized assistance is needed. + Prioritization and Queue management + Identify and escalate situation requiring urgent attention + Interact with users and co-workers (local & remote) to support identification and resolution of problems + Contribution to Knowledge Base #LI-LZ1 Qualifications: **Required Education/Skills/Experience:** + The position does not require long term work experience and so it is also suitable for graduates or students who would like to start their career in a corporate environment. + Proficiency in English. + Advanced knowledge of any other European language is a plus but not a requirement. + Basic technical skills at user level, Microsoft Office and Windows operating system literacy is required, Windows 10 knowledge is a plus. + Exceptional interpersonal and communication skills with high level of professionalism and strong customer orientation attitude. + Team player with a positive attitude. #LI-LZ1 About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Junior Global Service Desk Analyst Location: Europe, Middle East, Africa, Canada (EMEAC)-Czech Republic Job Number: 013636
Edwards Lifesciences Czech Colony, Sanath Nagar, Hyderabad, Telangana, India
Apr 18, 2018
The Staff Supplier Quality Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Marketing, Operations, Sourcing, and RA. **Responsibilities:** + Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures. + Works with suppliers to ensure quality system requirements are understood and successfully met. + Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier and Edwards receiving inspection Test method validation. + Ensures validation methods of critical 1st and 2nd tier suppliers are aligned with international standards, global regulations, and Industry best practices. + Supports completion of Design File requirements applicable to supplied components, devices, and services. + Facilitates risk management activities with suppliers. + Strong knowledge of CAPA elements is required. + Functions as a lead auditor for supplier audit program. + Assesses nonconformances and leads closure of supplier actions as needed. + Manage supplier Notification of changes. + Lead supplier management initiatives. #LI-LM1 Qualifications: **Qualifications:** + Bachelor’s degree in engineering with a minimum 6 years’ experience or master’s degree plus 5 years’ experience in medical device manufacturing. + Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred. Experience working with a regulated industry is required. + This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills is required. + Excellent documentation and communication skills and interpersonal/intercultural relationship skills including negotiating and relationship management skills. + Ability to work independently without close supervision. + Advanced understanding of V&V, statistical techniques, and risk management. + Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required. + Ability to read and interpret drawings. + Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects. + Certified Lead Auditor / ASQ Certified Biomedical Auditor preferred. + General understanding of plastic manufacturing or electronics assembly methods are a plus. + Understanding of active medical devices a plus. + Domestic and international travel is required. Expected 25% travel. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Staff Supplier Quality Engineer Location: USA-USA-California - Irvine Job Number: 013664
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
Provide administrative support across areas of quality for smooth and continuous operations. **Essential Job Functions:** + Review performance and training records of quality staff to ensure that they are appropriately trained and certified for assigned work, and may conduct SOP/procedural training. + Schedule work order sequencing to ensure plan is met, including maintains team performance metrics. + Perform JDE transactions, and may be JDE Super User, that include back flush (close operations), terminate components to floor stock, and perform cycle counts. + Mediate technical documentation issues directly with engineering staff. + Escalate quality and staff issues to supervisor. + May assist employees in accurately recording time, including escalating issues to supervisor for correction. + May lead and/or participate in procedural compliance audits. + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. #LI-MA1 Qualifications: **Required Education:** + H.S. Diploma or equivalent with 6 years of directly related experience, including leading assembly/quality work teams is required. + Additional previous assembly/quality line experience in a related industry is preferred. **Required Skills:** + Proven expertise in Microsoft Office Suite and ERP (Enterprise Resource Planning) system, preferably JDE + Excellent communication and interpersonal relationship skills + Strong English language skills, including reading, comprehending, speaking and writing + Advanced level of understanding of quality procedures + Advanced user in manufacturing and quality software, which typically includes JDE + Practical application to complex problems and situations ordinarily encountered + Knowledgeable in all quality processes for multiple models and other production areas (model/operation) + Ability to guide other workers/colleagues in understanding operations and quality standards + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures + Strict attention to detail in regards to work orders, scheduling, and documentation + Must be able to work in a team environment and with minimum supervision by following detailed quality instructions + Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Group Leader, Quality Location: USA-USA-California - Irvine Job Number: 013667
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
Edwards’ has an exciting leadership opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease. **Role Purpose:** The Director will be responsible for overseeing the Indication Expansion (IE) and Sustaining clinical research portfolio related to transcatheter heart valve devices (THV). Reporting to the Sr. Director, Clinical Research, this individual will partner closely with the Directors of Clinical Strategy, Clinical Development and Trial Operations to develop optimized and comprehensive divisional and regional research studies for all indication expansion and sustaining studies. She/he will directly manage a global team of project managers. This role is responsible for providing input to the Director of Clinical Strategy for region specific study design as well as providing key R&D input and feedback. The Director for IE will collaborate with the Sr. Director, Global Trial Operations or designee to ensure adequate staff and timelines for program execution as well as, with Directors in R&D, Medical Affairs, and Product Marketing as needed to incorporate technical and voice of customer inputs on product improvements or indication needs and study design and execution. This leader and direct reports will be required to interact with global KOLs, conduct regulatory negotiations, educate self and others on all aspects of the program design, technology, strategy and status and provide cross-functional business updates and competitive intel routinely. **Major Job Functions:** + Is the face of the Indication Expansion and Sustaining clinical research portfolio and is able to go deep on the technology and rationale for trial designs (both internally and externally). + Is responsible for the planning and execution of I/E and Sustaining research. Position will collaborate with cross-functional groups to ensure program success. + Ensures the on time execution of the I/E and sustaining trials globally and related activities are achieved per annual operating and scientific plan in collaboration with the Director of Strategy and Sr. Director of Global Trial Operations or designee and in accordance with global clinical processes, regulations and good clinical practices. + Ensures all safety surveillance and monitoring, identification and reporting of adverse events and device-related complications are submitted in accordance with regulatory and corporate/divisional requirements. Works through others to achieve. + Collaborates with the Sr. Director of Trial Operations to confirm that the management and maintenance of site and internal research documentation are handled in accordance with established Standard Operating Procedures (SOP´s) and regional research directives and guidelines for agency/internal auditing. + Maintains regular contact with cross-functional leaders (Finance, Marketing, Sales, R&D, etc.) for the exchange of study related information. + Ensures the proper management and training of direct reports/staff. + Verifies the accuracy of clinical data presentations for Regulatory submissions, annual reports, conferences and study meetings (Executive Committees, DSMB, CEC, Steering Committees); ensures relevancy. + Is flexible and forward thinking to modify research strategies as new evidence is discovered. #LI-JB1 Qualifications: **Required Experience:** + Highly preferred educational focus in medical, or biological sciences. Bachelor’s degree required. PhD, MD, MBA preferred. + More than 12 years with Master’s degree (14 with Bachelor’s), managing clinical studies or related clinical programs preferably on cardiovascular medical devices. + Experience in clinical, regulatory and marketing aspects of medical device technology. + Advanced knowledge of international regulations of Good Clinical Practice (GCP), experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research. + Project management experience. + Clinical strategy experience. + Management of clinical trial steering committees. + Supervision or mentoring of subordinates. + Trial budget creation and management experience required. **Required Education/Skills:** + Computer skills – Microsoft Office (Word, Excel, Access, PowerPoint), Internet. + Knowledge of basic biostatistical and actuarial methods; + Familiarity with hospital environment. + Good communication and organizational skills. + Strong leadership skills. + Thorough conscientious and results oriented working style; + Team oriented. + Independent judgment skills & action orientation for obtaining required results. + Able to forecast and manage large research budgets. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Director, Clinical Research – Indication Expansion - Transcatheter Heart Valve Location: USA-USA-California - Irvine Job Number: 013665
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
The Principal Supplier Quality Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Marketing, Operations, Sourcing, and RA. **Responsibilities:** + Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures. + Works with suppliers to ensure quality system requirements are understood and successfully met. + Responsible for defining supplier qualification requirements for OEM, Contract manufacturing items and custom materials. + Ensures validation methods of critical 1st and 2nd tier suppliers are aligned with international standards, global regulations, and Industry best practices. + Supports completion of Design File requirements applicable to supplied components, devices, and services. + Facilitates risk management activities with suppliers. + Strong knowledge of CAPA elements is required. + Functions as a lead auditor for supplier audit program. + Assesses nonconformances and leads closure of supplier actions as needed. + Manage supplier notification of changes. + Lead supplier management projects. + Mentor team members and cross-functional peers as needed. + Work with supplier quality council and help establish departmental processes and systems as needed. #LI-LM1 Qualifications: **Qualifications:** + Bachelor’s degree in engineering with a minimum 10 years’ experience or master’s degree plus 8 years’ experience in medical device manufacturing. + Knowledge and understanding of FDA and international regulatory standards for medical devices is required. + This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills is required. + Excellent documentation and communication skills and interpersonal/intercultural relationship skills including negotiating and relationship management skills. + Ability to work independently without close supervision. + Advanced understanding of V&V, statistical techniques, and risk management. + Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required. + Ability to read and interpret drawings. + Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects. + Certified Lead Auditor / ASQ Certified Biomedical Auditor preferred. + General understanding of plastic manufacturing or electronics assembly methods are a plus. + Understanding of active medical devices a plus. + Domestic and international travel is required. Expected 25% travel. + Ability to mentor and manage junior engineers is a plus. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Principal Supplier Quality Engineer Location: USA-USA-California - Irvine Job Number: 013663
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
The Quality Analyst will be responsible for handling all aspects of customer complaints for our ground breaking Transcatheter Heart Valve devices. This includes conducting and facilitating investigations, risk assessment activities, and Corrective/ Preventive Action(s) as required to reduce complaint rates and to incorporate this information into risk management documentation. This role will support the complaints investigation engineering team and work side by side with Quality and R&D engineers in device investigations and the completion and closure of engineering reports. This is a newly created opportunity in a fast paced and rapidly growing organization. **Job responsibilities include:** + Perform and complete assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and initiate and complete engineering investigation reports. + Perform investigation report reviews for ensure the accuracy and appropriateness of content. + Facilitate with cross functional groups such as R&D, Manufacturing Engineering, and Production to ensure Quality problem resolution by means of Root Cause/Problem Solving Analysis. + Follow up on Implementation of corrective and preventive actions as required. + Development/ update of risk management documentation (i.e. Medical Device Hazard Analysis, Process Failure Modes and Effects Analysis) for products manufactured, as required. + Support external regulatory requests with complaint risk and metric analysis as needed. + Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data. #LI-MA1 Qualifications: **Experience / Education / Special Requirements:** + Bachelor’s degree or equivalent related field 3 years required. Bachelor’s degree in a field of study related to math, science, engineering or health sciences preferred. + Previous experience in a laboratory, research or medical device development, manufacturing or quality assurance role is required. + Prior experience in the medical device industry is preferred as proficiency with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems will be critical to the success in this position. + A proficiency in technical writing is required. + Strong communication, project management, and interpersonal skills is required. + Prior experience in problem solving methodology, root cause analysis and GDP (good documentation practices) is preferred. + Experience in Microsoft Office software suite preferred. + Basic understanding of statistical concepts preferred. + Experience working in a dynamic team environment is preferred. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Quality Analyst - Transcatheter Heart Valve Location: USA-USA-California - Irvine Job Number: 013675
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
We are looking for an experienced analytical chemist with extensive expertise in analytical testing to join our high-paced, and dynamic team of experienced chemists. The position will be primarily responsible for managing projects, developing complex technical protocols, reports, validating new test methods, qualifying new equipment and conducting material characterization using HPLC-MS as well as GC-MS and ICP-MS as part of Extractables and Leachables. **Essential Job Functions:** + Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams while drive the science and changes in the science of chemistry (e.g., (EQL) EW Quality Laboratory study directors, (L/E) leachable and extractable) + Lead the test method development, validation and routine/in-process testing on Extractables and Leachables using high performance liquid chromatography mass spectrometry (HPLC-MS), gas chromatography mass spectrometer (GC-MS) and inductively coupled mass spectrometer (ICP-MS). + Lead laboratory operations activities including maintaining work schedules to align with production + Ability to interact with senior external representatives (e.g., regulatory agencies, FDA, DEKRA, TUV, MHLW) on significant technical matters often requiring coordination between organizations. + Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures + Drive compliance, policy and procedures chemical activities + Support complex process improvement projects (e.g., BEST, Lean) and work with team to provide solutions + Perform testing as needed #LI-MA1 Qualifications: **Required Education:** + Bachelor's Degree in Chemistry plus 10 years of experience Or + Master's Degree in Chemistry plus 8 years of experience Or + Ph.D. Degree in Chemistry plus 6 years of experience. **Required Skills:** + Proven successful project management skills + Proven expertise in MS Office; Analytical Equipment System (e.g., ChemStation, Empower) + Excellent facilitation and presentation skills + Excellent problem-solving, organizational, analytical and critical thinking skills + Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives + Expert knowledge and understanding of analytical chemistry principles, theories and concepts + Expert knowledge of laboratory equipment (e.g., gas Chromatography, high performance liquid chromatography, total organic carbon, Fourier transform infrared spectroscopy, atomic absorption) + Deep knowledge and expertise in medical devices, and capability to propose necessary testing to establish the safety/biocompatibility of medical devices and their compliance with regulatory agencies guidelines + Extensive knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO 10993) + High energy, and resourceful person who is capable of quickly taking control of his responsibilities, building capable strategies and establishing himself as a credible strategic partner + Ability to manage confidential information with discretion + Strong leadership skills and ability to influence change + Knowledge of Environmental Health and Safety and Quality guidelines + Strict attention to detail + Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment + Ability to interact professionally with all organizational levels + Work very well with customer, and communicate main technical issues and progress of the projects + Ability to manage competing priorities in a fast paced environment + Ability to work in a team environment, including representing organization as key technical contact on contracts and projects + Ability to interact with senior external representatives (e.g., regulatory agencies, FDA, DEKRA, TUV, MHLW) on significant technical matters often requiring coordination between organizations About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Principal Chemist Location: USA-USA-California - Irvine Job Number: 013674
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
This role is to be a key member of the newly created Global Supply Chain Pilot Operations site in Irvine tasked to support New Product Development and transfer of new products to a sustaining site after commercialization. It will support primarily the CENTERA Transcatheter Aortic Valve Replacement System and will have direct oversight of 2-4 inspectors related to the production and testing operations in 2nd shift. This is a 2nd Shift Quality Engineering position with a schedule of Monday thru Friday 12pm-9pm. This role applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Job Functions:** + Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports + Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work + Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk + Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes + Train, coach, and guide lower level employees on more complex procedures #LI-LM1 Qualifications: **Required Education & Skills:** + Bachelor’s degree in engineering or scientific field and 6 years minimum experience in related industry (medical device, pharma, biotech, etc) + Proven expertise in usage of MS Office Suite + Ability to read and interpret drawings + Proven expertise in statistical techniques + Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills + Ability to translate technical information to all levels of the organizations + Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge) + Knowledge of Six Sigma concepts with ability to apply to work product + Knowledge of Quality Engineering concepts with ability to apply to work product + Advanced problem-solving, organizational, analytical and critical thinking skills + Extensive understanding of processes and equipment used in assigned work + Strong leadership skills and ability to influence change + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Strict attention to detail + Experience in ETQ Reliance, Ignite PLM, and JDE ERP software systems highly preferred + Six-Sigma and CQE certifications strongly preferred About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Staff Quality Engineer - Pilot CENTERA 2nd shift Location: USA-USA-California - Irvine Job Number: 013662
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
Edwards’ has an exciting leadership opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease. **Role Purpose:** The Director will be responsible for overseeing the New Product Development (NPD) clinical research portfolio related to transcatheter heart valve devices (THV). Reporting to the Sr. Director, Clinical Research, this individual will partner closely with the Directors of Clinical Strategy, Clinical Development and Trial Operations to develop optimized and comprehensive divisional and regional research studies for all new product development (NPD) technology. She/he will directly manages a global team of project managers. This role is responsible for providing input to the Director of Clinical Strategy for region specific study design as well as providing key R&D input and feedback. The Director for NPD will collaborate with the Sr. Director, Global Trial Operations or designee to ensure adequate staff and timelines for program execution as well as, with Directors in R&D, Medical Affairs, and Product Marketing as needed to incorporate technical and voice of customer inputs on product and study design and execution. This leader and its direct reports will be required to interact with global KOLs, conduct regulatory negotiations, educate self and others on all aspects of the program design, technology, strategy and status and provide cross-functional business updates and competitive intel routinely. **Major Job Functions:** + Is the face of the NPD clinical research portfolio and is able to go deep on the technology and rationale for trial designs (both internally and externally). + Is responsible for the planning and execution of First in Man, Early Feasibility, Feasibility and Compassionate use programs. Position will collaborate with cross-functional groups to ensure program success. + Ensures the on time execution of the NPD trials globally and related activities are achieved per annual operating and scientific plan in collaboration with the Director of Strategy and Sr. Director of Global Trial Operations or designee and in accordance with global clinical processes, regulations and good clinical practices. + Ensures all safety surveillance and monitoring, identification and reporting of adverse events and device-related complications are submitted in accordance with regulatory and corporate/divisional requirements. Works through others to achieve. + Collaborates with the Sr. Director of Trial Operations to confirm that the management and maintenance of site and internal research documentation are handled in accordance with established Standard Operating Procedures (SOP´s) and regional research directives and guidelines for agency/internal auditing. + Maintains regular contact with cross-functional leaders (Finance, Marketing, Sales, R&D, etc.) for the exchange of study related information. + Ensures the proper management and training of direct reports/staff, + Verifies the accuracy of clinical data presentations for Regulatory submissions, annual reports, conferences and study meetings (Executive Committees, DSMB, CEC, Steering Committees); ensures relevancy. + Is flexible and forward thinking to modify research strategies as new evidence is discovered. #LI-JB1 Qualifications: **Required Experience:** + Highly preferred educational focus in medical, or biological sciences. Bachelor’s degree required. PhD, MD, MBA preferred. + More than 12 years with Master’s degree (14 with Bachelor’s) managing clinical studies or related clinical programs preferably on cardiovascular medical devices. + Experience in clinical, regulatory and marketing aspects of medical device technology. + Advanced knowledge of international regulations of Good Clinical Practice (GCP), experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research. + Project management experience. + Clinical strategy experience. + Management of clinical trial steering committees. + Supervision or mentoring of subordinates. + Trial budget creation and management experience required. **Required Education/Skills:** + Computer skills – Microsoft Office (Word, Excel, Access, PowerPoint), Internet. + Knowledge of basic biostatistical and actuarial methods; + Familiarity with hospital environment. + Good communication and organizational skills. + Strong leadership skills. + Thorough conscientious and results oriented working style. + Team oriented. + Independent judgment skills & action orientation for obtaining required results. + Able to forecast and manage large research budgets. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Director, Clinical Research – New Product Development - Transcatheter Heart Valve Location: USA-USA-California - Irvine Job Number: 013666
Edwards Lifesciences Irvine, CA, USA
Apr 18, 2018
This is an exceptional opportunity to join a premier Global Health Economics & Reimbursement (GHER) team that is playing a key role in the success of our Critical Care Therapies. You will be responsible for assisting in the development and implementation of market access strategies to support our CC business unit. This position is based at the corporate headquarters in Irvine, California. Primary Responsibilities: + In collaboration with cross-functional teams, identify and develop strategies and tactics to enhance the value proposition of CC products, including, but not limited to the creation of health economics and outcomes research (HEOR) programs. + Help develop economic models, dossiers, presentations and other materials to enhance the Value Message associated with our CC technologies. + Develop education tools related to innovative methodologies for quantifying patient outcomes related to preference / function through synthesis and analysis of literature (e.g. patient preference methodologies, actigraphy) + Assist team with due-diligence projects and support new product development from a Health Economics and Reimbursement perspective. + Generate evidence and develop strategies to support Coverage, Coding and Payment for existing and future CC products. + Use analytical skills and judgment to solve problems with limited information at hand. + Get work done through cooperation with other groups with no direct reporting relationship to position Qualifications: Minimum Qualifications: + Bachelor’s degree in a life science, health economics, health policy, or related field preferred + Working toward an advanced degree (e.g. MBA, MPH, MD, Pharm.D.) is desirable + Strong background in health economics and outcomes research is a plus + Clinical knowledge in critical care is preferred but not required + Ability to breakdown complex information and apply to key business needs/requirements + Willing to take initiative on complex projects and able to identify what is necessary to complete tasks + Excellent interpersonal and communication skills, especially presentation development + Ability to balance strategic thinking with intricate planning and strong tactical execution + Understanding of key public and private payer policy infrastructure, payment methodologies coding and coverage; health policy trends, and current business challenges About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Global Health Economics and Reimbursement (GHER) Intern - Critical Care Location: USA-USA-California - Irvine Job Number: 013676
Edwards Lifesciences Irvine, CA, USA
Apr 17, 2018
Ensures the transfer of materials as needed for manufacturing to ensure continuous production, in compliance with local EH&S guidelines, Edwards procedures, and other applicable regulations. Shift: 5:00 a.m.-3:30 p.m. Monday-Thursday Key Responsibilities: + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. + Enter components and/or materials status in JDE to allow availability in clean room floor stock + Monitor, distribute, and maintain raw materials supply levels for product assembly process in the clean room, to ensure availability as needed, including assuring all items are stored in the appropriate place for ease of accessibility, in compliance with SOPs + Transport products between operations and place appropriate materials in each work station in the line clearance process + Prepare and distribute material kits for production + Perform inventory cycle counts and physical inventory counts, including resolving discrepancies + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period + Other incidental duties: General work area housekeeping, other tasks as required by leadership #LI-BP1 Qualifications: Education and Experience: + H.S. Diploma or equivalent is required + Previous experience with medical device process is preferred Additional Skills: + Good communication skills + Ability to read, comprehend, and speak English sufficiently to complete work documentation + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Must be able to work with minimum supervision by following SOPs and/or other instructions + Work in a Team environment, primarily with peers in Production Supply and Manufacturing + Good computer skills, required + Flexibility to work varying shifts and/or overtime, as needed About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Associate Production Supply, EPC/MIS Location: USA-USA-Utah - Draper Job Number: 013542
Edwards Lifesciences Draper, UT, USA
Apr 17, 2018
Ensures the transfer of materials as needed for manufacturing to ensure continuous production, in compliance with local EH&S guidelines, Edwards procedures, and other applicable regulations. Shift: 5:00 a.m.-3:30 p.m. Monday-Thursday Key Responsibilities: + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. + Enter components and/or materials status in JDE to allow availability in clean room floor stock + Monitor, distribute, and maintain raw materials supply levels for product assembly process in the clean room, to ensure availability as needed, including assuring all items are stored in the appropriate place for ease of accessibility, in compliance with SOPs + Transport products between operations and place appropriate materials in each work station in the line clearance process + Prepare and distribute material kits for production + Perform inventory cycle counts and physical inventory counts, including resolving discrepancies + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period + Other incidental duties: General work area housekeeping, other tasks as required by leadership #LI-BP1 Qualifications: Education and Experience: + H.S. Diploma or equivalent is required + Previous experience with medical device process is preferred Additional Skills: + Good communication skills + Ability to read, comprehend, and speak English sufficiently to complete work documentation + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Must be able to work with minimum supervision by following SOPs and/or other instructions + Work in a Team environment, primarily with peers in Production Supply and Manufacturing + Good computer skills, required + Flexibility to work varying shifts and/or overtime, as needed About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Associate Production Supply, EPC/MIS Location: USA-USA-Utah - Draper Job Number: 013544
Edwards Lifesciences Draper, UT, USA
Apr 17, 2018
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details. **Key Responsibilities:** + Investigate basic manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. + Optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. + May develop, update, and maintain technical content of risk management files. + Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. + Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinates technician work. + Other incidental duties assigned by Leadership. Qualifications: **Education and Experience:** + Bachelor's Degree or equivalent in engineering or scientific field, no related work experience required Or + Master's Degree or equivalent in engineering or scientific field, no related work experience required. **Additional Skills:** + Good computer skills in usage of MS Office Suite; CAD experience preferred. + Basic documentation, communication and interpersonal relationship skills. + Basic understanding of statistical techniques. + Previous experience working with lab/industrial equipment preferred. + Good understanding and knowledge of principles, theories, and concepts relevant to Engineering. + Good problem-solving, organizational, analytical and critical thinking skills. + Good understanding of processes and equipment used in assigned work. + Knowledge of and adherence to Quality systems. + Strict attention to detail. + Ability to interact professionally with all organizational levels. + Ability to manage competing priorities in a fast paced environment. + Must be able to work in a team environment, including immediate supervisor and other team members in the section or group. + Ability to build stable working relationships internally. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Engineer I, Quality--Product Verification Lab Location: USA-USA-Utah - Draper Job Number: 012430
Edwards Lifesciences Draper, UT, USA
Apr 17, 2018
Ensures the transfer of materials as needed for manufacturing to ensure continuous production, in compliance with local EH&S guidelines, Edwards procedures, and other applicable regulations. **Key Responsibilities:** + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. + Enter components and/or materials status in JDE to allow availability in clean room floor stock. + Monitor, distribute, and maintain raw materials supply levels for product assembly process in the clean room, to ensure availability as needed, including assuring all items are stored in the appropriate place for ease of accessibility, in compliance with SOPs. + Transport products between operations and place appropriate materials in each work station in the line clearance process. + Prepare and distribute material kits for production. + Perform inventory cycle counts and physical inventory counts, including resolving discrepancies. + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. + Other incidental duties: General work area housekeeping, other tasks as required by leadership. #LI-JE1 Qualifications: **Education and Experience:** + H.S. Diploma or equivalent is required. + Previous experience with medical device process is preferred. **Additional Skills:** + Good communication skills. + Ability to read, comprehend, and speak English sufficiently to complete work documentation. + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing. + Must be able to work with minimum supervision by following SOPs and/or other instructions. + Work in a Team environment, primarily with peers in Production Supply and Manufacturing. + Good computer skills, required. + Flexibility to work varying shifts and/or overtime, as needed. About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: 2nd Shift Associate Production Supply – Transcatheter Heart Valve Location: USA-USA-Utah - Draper Job Number: 013135
Edwards Lifesciences Draper, UT, USA
Apr 17, 2018
Ensures the transfer of materials as needed for manufacturing to ensure continuous production, in compliance with local EH&S guidelines, Edwards procedures, and other applicable regulations. **Key Responsibilities:** + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. + Enter components and/or materials status in JDE to allow availability in clean room floor stock + Monitor, distribute, and maintain raw materials supply levels for product assembly process in the clean room, to ensure availability as needed, including assuring all items are stored in the appropriate place for ease of accessibility, in compliance with SOPs + Transport products between operations and place appropriate materials in each work station in the line clearance process + Prepare and distribute material kits for production + Perform inventory cycle counts and physical inventory counts, including resolving discrepancies + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period + Other incidental duties: General work area housekeeping, other tasks as required by leadership #LI-JE1 Qualifications: **Education and Experience:** + H.S. Diploma or equivalent is required + Previous experience with medical device process is preferred **Additional Skills:** + Good communication skills + Ability to read, comprehend, and speak English sufficiently to complete work documentation + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Must be able to work with minimum supervision by following SOPs and/or other instructions + Work in a Team environment, primarily with peers in Production Supply and Manufacturing + Good computer skills, required + Flexibility to work varying shifts and/or overtime, as needed About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: 2nd Shift Associate Production Supply – Transcatheter Heart Valve Location: USA-USA-Utah - Draper Job Number: 013241
Edwards Lifesciences Draper, UT, USA
Apr 17, 2018
Edwards Lifesciences is looking for someone to join the team as a component cleaner. Individuals in this role will be responsible for cleaning and washing the components used to assemble medical devices. Key Responsibilities: + Use tools and equipment to complete assembly of medical devices precisely and in a timely fashion at each work station – proficient in multiple operations – following work order instructions and drawings, using computers to navigate drawings, and entering parts status data. Inventory reconciliation at start of day and when transitioning to next work order. + Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter data into manufacturing data systems. + Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build. + Self-assessment of work, which may include visual inspection under magnification, and sequential review of colleagues work, providing constructive team feedback, including escalating work issues and changes in equipment performance to supervisor for assessment and correction. + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period + Other incidental duties: General work area housekeeping #LI-JE1 Qualifications: Education and Experience: + H.S. Diploma or equivalent preferred Additional Skills: + Good communication skills + Able to read, comprehend and speak English, and elementary-level understanding of numerical functions + Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing + Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures + Must be able to work with minimum supervision by following detailed manufacturing instructions + Work in a Team environment, primarily work with colleagues and supervisor + Ability to effectively provide and accept feedback from colleagues based on sequential work reviews + Flexibility to work overtime to ensure smooth and continuous manufacturing processes + Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures About Edwards Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities. Title: Component Cleaning - Transcatheter Heart Valve Location: USA-USA-Utah - Draper Job Number: 013305
Edwards Lifesciences Draper, UT, USA