Sr. Device Development Engineer- Product Design
About The Position
Regeneron is seeking a Device Development Engineer to join its Combination Drug Product Development group. The role contributes to designing innovative specialty drug delivery devices for the company’s product pipeline, helping advance medicines for patients worldwide. Depending on the project and level, the engineer may lead or participate in combination product development, including project leadership, technical product engineering, design transfer, and secondary packaging. The role supports development of next-generation injection devices and works with program management and cross-functional teams to plan and deliver projects from concept through clinical and commercial launches. The engineer evaluates designs using engineering calculations, finite element analysis (FEA) with ANSYS, and statistical tolerance stacking with Excel and Sigmetrix Cetol 6σ. They help ensure products developed internally and externally are technically robust, reliable, and compliant with applicable regulations and industry standards. They also identify and mitigate project risks, propose solutions, and support continuous improvement aimed at product safety, efficacy, and timely delivery. The position is based in East Greenbush, New York. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m., with approximately 5% domestic travel and occasional international travel. The job is expected to be performed on-site in many cases; applicants should confirm expectations with the recruiter or hiring manager.
Requirements
- Bachelor of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field.
- For the Engineer level, 2 or more years of experience in product development or engineering.
- For the Sr. Engineer level, 5 or more years of experience in product development or engineering.
- Experience in the medical device industry and in developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
- Experience with SolidWorks, CAD, or similar tools.
Nice To Haves
- Experience with design controls.
- Experience with tolerance stacking.
- Molding or machining expertise.
- Experience developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971.
Responsibilities
- Implement combination product development projects on time, within scope, and within budget.
- Lead or contribute to project leadership, technical product engineering, design transfer, and secondary packaging.
- Support development of next-generation injection devices.
- Work with program management to identify and plan tasks required to take projects from concept through clinical and commercial launches.
- Evaluate designs using engineering calculations, FEA with ANSYS, and statistical tolerance stacking with Excel and Sigmetrix Cetol 6σ.
- Work closely with multifunctional teams to support project success.
- Conduct engineering analyses to help ensure internally and externally developed products are technically robust and perform sufficiently and reliably.
- Identify project risks, mitigate issues and risks promptly, and propose solutions.
- Ensure work activities align with applicable regulations and industry standards.
- Promote continuous improvement to support product safety and efficacy and accelerate delivery of commitments.
Benefits
- Annual bonuses or other incentive plans may be offered, depending on country and role.
- Equity awards may be offered, depending on country and role.
- Pension or retirement benefits may be offered, depending on country and role.
- 401(k) company match may be offered, depending on country and role.
- Health and wellness programs may be offered, depending on country and role.
- Fitness centers may be available, depending on country and role.
- Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
- Paid time off may be offered, depending on country and role.
- Family support benefits may be offered, depending on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
