Regeneron · 12 hours ago
Device Development Engineer (Project Leadership)
East Greenbush, NY
Full-time
Onsite
New Grad, Entry, Mid, Senior Level
$66K/yr - $144K/yr
0+ years expRegeneron is seeking a Device Development Engineer to join their project lead team. The role involves driving the end-to-end development of a device combination product and providing leadership in engineering product management and regulatory compliance.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Leads multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of a combination product development within the Regeneron Pipeline
Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy collaborators
Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.)
Responsible for all user needs and requirements to be validated through design and development
Develops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members
Integrate device development activities with Chemistry Manufacturing Controls (CMC) and Global development timing and goals
Supports global internal manufacturing and external manufacturing teams around relevant design and process development information transfers
Leads all aspects of product testing and quality assurance processes for the specific device development
Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30)
Supports management in related clinical and commercial regulatory activities that is related to the device development (ie: IND/IMPD, BLA Submission, Clinical Pharmacy Manuals etc.)
Understands design inputs and outputs of multiple delivery systems and how it can impact end users
Supports management and/or therapeutic area device project leads, in strategic product launch and go-to-market plans for the device development
Qualification
Required
B.S in Engineering
0-2 years of relevant experience for Associate Device Development Engineer
2+ years of relevant experience for Device Development Engineer
5+ years of relevant experience for Sr. Device Development Engineer
Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30
Strong project management and interpersonal skills
Strong analytical and problem-solving capabilities
Ability to balance business objectives with technical constraints
Ability to work effectively across multiple functional teams
Willingness and ability to travel for partner meetings, audits, and project coordination activities
Preferred
Experience with design history file management (21 CFR 820.30)
Previous experience in product management/project management/ and/or project leadership related activities
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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