Apr 19, 2018
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, fibrosis and others. We have built a sustainable pipeline of potential therapies, and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient at the right time to achieve the best outcome.
Bristol-Myers Squibb gives you the opportunity to learn and grow professionally alongside smart, creative and talented colleagues who are committed to helping patients battle serious diseases. Doing amazing things with people you like and admire isn’t something you can find just anywhere.
We believe in a Total Rewards experience that enriches your life today and engages and empowers you to save, perform, grow, and build toward all of your tomorrows. We foster an energizing work experience, that through your choices, education and access, sustains our environment of well-being, individual accountability, productivity and safety.
We now have an opening for a Product Design Senior Engineer for Medical Device / Combination Products.
Specific responsibilities include:
+ Serve as lead design engineer in development projects, perform and coordinate design reviews and assess technical solutions.
+ Generate new drug delivery device concepts, documented by hand sketches, CAD models and/or text descriptions.
+ Build “looks like” (form) and “works like” (function) prototype models.
+ Plan, conduct, analyze and document human factors activities.
+ Design experiments using DOE methodology and analyze the test results using statistical tools.
+ Lead efforts in creating custom methods and equipment for testing components, delivery devices and systems.
+ Identify, select and manage external resources (device vendors, service providers and third-party manufacturers).
+ Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability.
+ Contribute to the preparation of regulatory submissions (per 21 CFR 820.30, 21 CFR part 4).
+ Liaison with the Intellectual Property department to ensure FTO clearance and intellectual property protection.
+ Collaborate with other teams at functional, departmental and divisional level to ensure robust definition of product requirements.
+ Maintain a high state of awareness of the competitive landscape and state-of-the art in drug delivery and identification of trends in clinical practice and regulatory landscape.
+ Participate in the development and evolution of the company’s CAD infrastructure, design tools and product development process.
+ BS degree in Mechanical Engineering, Product Design, Industrial Design or relevant engineering discipline. Advanced degree a plus.
+ Minimum of 8 years of product development experience with a strong track record of achievement. Direct experience with medical devices, combination products, and/or drug delivery technologies a plus.
+ Strong technical skills and creative ability a must. Mastery of the fundamentals of engineering, with a focus on mechanisms, materials, fluidics and physics. Knowledge of manufacturing processes such as machining, metal forming, injection molding and assembly operations.
+ Ability to generate technical sketches and 3D CAD models/renderings needed. Comfortable building and testing prototypes.
+ Ability and willingness to generate documentation (test protocols, completion reports, product/process specifications, invention disclosures, etc.). Experience with design control in a medical device FDA regulated design environment is preferred. Strong communication skills and ability to work in a collaborative team environment a must.
+ Pro-active, self-motivated personality.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
New Brunswick, NJ, USA