Medical Device Quality Engineer
Regeneron Pharmaceuticals
Summary
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.
Job description
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- 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 data/statistical/trend analysis as needed.
- Ensures work product meets regulations.
- Writes Quality Procedures, as applicable.
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
Requirements
- 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
Benefits
- Annual bonuses
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.