Note: The job is a remote job and is open to candidates in USA. 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.
Responsibilities
- 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
Skills
- 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
- 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.
Company Overview
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