Senior Design Quality Engineer (Mansfield, MA)
Core
Ensuring design controls are robust and compliant with regulations for new sports medicine joint repair products.
Role type
Senior Design Quality Engineer
Builds
Safe and effective medical device products for the sports medicine market
Domain
Medical device / Sports medicine / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management planning, FMEA, design transfer activities, test method validation, measurement systems analysis, engineering design documentation, regulatory submissions, process improvement initiatives
Preferred skills
CQE certification, Six Sigma certification
Technologies
FDA QSR, ISO 13485, ISO 14971
Responsibilities
Lead risk management planning and FMEA; lead quality design transfer activities including test method validation; develop and release engineering design documentation; provide quality input to product user needs and design specifications; support design verification testing and usability testing; assist in preparation for regulatory submissions; lead identification and implementation of process improvement initiatives
Seniority
Senior, hands-on IC
