Sr. Device Development Engineer- Product Design

Build our future together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Device Development Engineer to join our Combination Drug Product Development group! In this role you will participate in and/or be the lead creative mind responsible for the design of innovative specialty drug delivery devices to address emerging needs in Regeneron's product pipeline, advancing medications getting delivered to patients in need around the world.

When & where

• Location: East Greenbush, NY, United States
• Shift: Monday-Friday- 8-4:30pm
• Travel: 5% domestic, sometimes international

Discover your role

• 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

This role requires

• BA/BA in Engineering or a related field
• 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
• Level is determined based on qualifications relevant to the role
• Experience with design controls, tolerance stacking, molding/machining expertise preferred
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 preferred