New · posted Nov 13
Regeneron · Biotechnology
Medical Device Quality Engineer
- East Greenbush, NY
- On-site
- Full-time
- Associate & Specialist
The role
Build our future together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. The Medical Device Quality Engineer provides Quality Assurance support and guidance to ensure compliance in support of combination products for biological therapeutics developed in-house and in collaboration with partners and CMO’s.
What you need
This role requires
- Bachelor’s degree in engineering.
- Experience working in either combination products or medical devices.
- Associate Engineer: 0 – 2 years of experience
- Engineer: 2 years of experience
- Senior Engineer: 5 years of experience
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
What you'll do
Discover your role
- Reviews and supports Design and Development documentation for compliance to internal procedures and regulations.
- Reviews activities related to Design Verification, Design Validation and Design Transfer during development of medical devices and combination products.
- Provides quality and technical support for the evaluation of change assessments for medical devices and combination products.
- Authors, leads and contributes to Risk Management activities including FMEAs.
- Reviews and coordinates with QA and various laboratory groups for test method development and test method validations.
- Ensures proper justification of statistical analysis and hypothesis testing.
- Aids in establishing proper statistical controls in development and transfer to manufacturing processes.
- Supports scientific, complaint and test failure investigations for medical devices and combination products.
- Supports actions required because of updates to standards and/or new applicable standards.
- Supports and contributes to CI initiatives for Med Device Quality.
- Performs tata/statistical/trend analysis as needed.
- Ensures work product meets regulations.
- Writes Quality Procedures, as applicable.
Pay and benefits
$66,200 – $143,900 a year
Employer provided$66,200.00 - $143,900.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
East Greenbush, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in East Greenbush, NYWorking conditions
When & where
- Location: East Greenbush, New York, United States
- Work model: Monday-Friday, 8:00 am - 4:30 pm
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% above the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,200 | — | $143,900 |
| All US (middle half) | $86,500 | $92,500 | $95,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 75 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance3
- Lab testing and methods3
- Documentation and SOPs2
- Validation and qualification2
- Collaboration and leadership2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Regeneron on Regulatory Jobs
- 172
- Open roles
- 172
- Distinct roles
- 12
- Locations
By discipline
- Clinical74 43%
- Quality72 42%
- Regulatory26 15%
By level
- Manager54 31%
- Director52 30%
- Associate & Specialist50 29%
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Medical Device Quality Engineer at Regeneron
Open until filled. $66K–$144K a year, employer provided.