Product Development Senior Engineer for Medical Device/Combination Products

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 Development Senior Engineer for Medical Device / Combination Products.

Specific responsibilities include:

• Responsible for cross-functional device development projects from concept through commercialization. Responsibilities include the selection, development, commercialization support, and lifecycle management of drug delivery devices for various drug products within BMS pipeline.
• Project activities include driving the establishment and validation of user requirements, translation into product/engineering specifications, design verification and validation activities, design reviews, design transfer and process validation activities, risk assessments, as well as post-market assessment activities leading to identification and implementation of potential product design improvements.
• Assess new technologies for drug delivery and leverage understanding of first engineering principles, customer needs, and technical judgment to assess device platforms against internal and external needs, with emphasis on safety, efficacy, user convenience, design robustness, manufacturability, and other BMS business objectives.
• Vendor selection and management - Identify best-in-class industry partners to establish business relationships and leverage existing technologies to develop innovative and differentiated delivery device platforms, balancing internal versus external investment and development activities.
• 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.
• Use advanced engineering skills to design experiments using DOE methodology and analyze the test results using statistical tools. Lead efforts in creating and developing methods and test stations for characterization, testing components, delivery devices and systems.
• Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities (per 21 CFR 820.30, 21 CFR part 4).

Qualifications

• BS degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus.
• Minimum of 8 years of device development (from concept through commercialization) experience in the Medical Device, Pharmaceutical, or Biotechnology industry for combination products.
• Broad and deep understanding of disciplined product development process, including design controls, design transfer, validations, and regulatory submission process.
• Strong cross-functional perspective, leadership and influencing capabilities within a matrix organization.
• Strong written and verbal communication skills, with special emphasis on technical writing for regulatory filings.
• Strong technical skills and familiarity with competitive landscape, industry trends, and regulatory environment for combination products.

This position is located in New Brunswick, NJ and may require up to 10% travel.

Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability

Job Function: Pharma Dev/Process Dev

Primary Location: NA-US-NJ-New Brunswick

Organization: R&D - PD - Drug Product Science & Technology