Medical Device Quality Engineer (Sustaining Engineering)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
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Role Summary
Medical Device Quality Engineer (Sustaining Engineering) – This position provides Quality Assurance oversight and ensures compliance in the support of combination device development life cycles.
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
Qualifications
- Bachelor’s degree in an Engineering subject area
- Associate Quality Engineer: 0-2 years (related internship preferred) or Quality Engineer: 2+ years in combination device or medical device industry
Skills
- Knowledge of the combination device development process
- Experience with device risk management activities
- Quality mindset
Education
- Bachelor’s degree in Engineering or related field
Additional Requirements
- Note: Salary range listed is for U.S.-based positions; other locations to be discussed with recruiter. Background checks may be conducted as part of the recruitment process.