Design Quality Engineer (Medical Device)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
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Role Summary
Design Quality Engineer (Medical Device) at Regeneron. This role provides Quality Assurance oversight and ensures 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
- Verify data integrity, electronic data storage and data sheet validations
- 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
- Experience: 0-2 years (Associate Quality Engineer); 2+ years (Quality Engineer); 5+ years (Sr. Quality Engineer) 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 an Engineering subject area
Additional Requirements
- Level determined based on qualifications relevant to the role