Senior Device Development Engineer (Project Leadership)
Regeneron Pharmaceuticals•Valley, AL
•$75,300 - $143,900•Onsite
About The Position
Regeneron is seeking a Senior Device Development Engineer to join their project lead team. This role will drive the end-to-end development of a device combination product and/or platform delivery system within a specific therapeutic area. The engineer will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi-functional collaboration with internal and external partners for the combination product device.
Requirements
- BS in Engineering and 5+ years of relevant experience; or equivalent combination of education & experience.
- Previous experience in product management/project management/ and/or project leadership related activities.
- Deep understanding of FDA regulations (21 CFR Part 4, 820.30) and DHF management experience.
- Strong project management, interpersonal, analytical, and problem-solving skills.
Responsibilities
- Leads multidisciplinary engineering teams (Human Factors, V&V, Manufacturing, Quality) through the full design and development lifecycle of combination products within the Regeneron pipeline.
- Defines product requirements, technical specifications, and design inputs in collaboration with commercial, clinical, and engineering stakeholders; ensures all user needs are validated through design and development.
- Understands design inputs/outputs across multiple delivery systems and their impact on end users.
- Develops, manages, and communicates program plans, risks, timelines, and budgets to internal and external teams.
- Integrates device development with CMC and global development timelines; supports internal/external manufacturing teams on design and process information transfer.
- Leads product testing and quality assurance processes; ensures a compliant Design History File (DHF) per 21 CFR Part 4 and 21 CFR 820.30.
- Supports clinical/commercial regulatory activities related to device development (IND/IMPD, BLA submissions, Clinical Pharmacy Manuals).
- Supports strategic product launch and go-to-market planning with therapeutic area device leads.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
