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) – Quality Engineer position focused on Quality Assurance oversight and regulatory compliance in the support of combination device development life cycles.
Responsibilities
- Review design and development paperwork and records for compliance to internal procedures and regulations
- Ensure accurate justification of statistical analysis and hypothesis testing
- Review technical reports and documents for Design History Files
- Participate in device risk management activities including UFMEA, DFMEA, PFMEA
- Aid in establishing statistical controls in development and transfer to manufacturing processes
- Review and coordinate with QA Validation for all test method and design validations
- Review activities related to Design Verification and Design Transfer of Medical Devices
- Ensure work product meets regulations
- Support scientific, complaint, and test failure investigations
- Perform data trend analysis, participate in Phase Reviews, write Quality Procedures, perform data/statistical analysis
Qualifications
- Required: Bachelor’s degree in an Engineering subject area
- Required: 2+ years of work experience in the combination device or medical device industry
- Preferred: Related internship experience
- Required: Knowledge of the combination device development process
- Required: Experience with device risk management activities
- Required: Quality mindset
Skills
- Quality Assurance and regulatory compliance
- Statistical analysis and hypothesis testing
- Design History File documentation
- Risk management (UFMEA, DFMEA, PFMEA)
- Validation and verification of medical devices
- Data trend analysis
Education
- Bachelor’s degree in an Engineering subject area
Additional Requirements
- Travel and physical demands not specified as essential