Regeneron is seeking a Senior Device Development Engineer to design specialty drug delivery devices for its product pipeline. The role supports combination product development from concept through clinical and commercial launches, including technical engineering, design transfer, engineering analysis, and cross-functional project work.
Implements combination product development projects on time, in scope, and within budget with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging
Support sophisticated solutions in developing next-generation injection devices
Working with program management to identify and plan tasks vital to developing a project from concept to clinical and commercial launches
Vetting designs with precise calculation, FEA (ANSYS), and statistical tolerance stacking with Excel and Sigmetrix Cetol 6σ
Works closely with multi-functional team to assure project success
Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably
Identifies areas of project risk, mitigate issues and risks in an expedient manner, and actively proposes solutions
Assures work activities are conducted in a manner aligned with all regulations and industry standards
Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments
Qualification
Required
Associate Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field
Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 2+ years of experience in product development or engineering
Sr. Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 5+ years of experience in product development or engineering
Experience in the medical device industry and the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971
Experience with Solidworks, CAD, or similar
Preferred
Experience with design controls, tolerance stacking, molding/machining expertise
Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971
Benefits
Annual bonuses or other incentive plans may be included, depending on country and role.
Equity awards may be included, depending on country and role.
Pension or retirement benefits may be included, depending on country and role.
401(k) company match may be included, depending on country and role.
Health and wellness programs may be included, depending on country and role.
Fitness centers may be included, depending on country and role.
Insurance benefits (e.g. medical, dental, vision, life and disability) may be included, depending on country and role.
Paid time off may be included, depending on country and role.
Family support benefits may be included, depending on country and role.
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
