Regeneron · 7 hours ago
Medical Device Quality Engineer (Sustaining Engineering)
East Greenbush, NY
Full-time
Onsite
New Grad, Entry, Mid Level
$65K/yr - $121K/yr
0+ years expRegeneron is seeking a Quality Engineer for their Medical Device Sustaining Engineering QA team. The role involves providing Quality Assurance oversight, ensuring compliance during the combination device development life cycle, and participating in various risk management activities.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Reviewing design and development paperwork and records for compliance to internal procedures and regulations
Ensuring accurate justification of statistical analysis and hypothesis testing
Reviewing technical reports as well as documents for Design History Files
Participating in device risk management activities including UFMEA, DFMEA, PFMEA
Aiding in establishing statistical controls in development and transfer to manufacturing processes
Reviewing and coordinating with QA Validation for all test method and design validations
Reviewing activities related to Design Verification and Design Transfer of Medical Devices
Ensuring work product meets regulations
Supporting scientific, complaint, and test failure investigations
Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis
Qualification
Required
Bachelor's degree in an Engineering subject area
0-2 years of work experience in combination device or medical device industry for Associate Quality Engineer
2+ years of work experience in combination device or medical device industry for Quality Engineer
knowledge of the combination device development process
experience with device risk management activities
quality mind-set
Preferred
related internship preferred
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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