Staff Design Quality Engineer (Mechanical)
Core
Provide quality support for new mechanical product development, ensuring designs meet safety, effectiveness, and reliability requirements while managing risk and validation.
Role type
Staff Design Quality Engineer (Mechanical)
Builds
Medical device products and manufacturing processes
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management planning, Design verification and validation, Process controls, Human factors usability engineering, Critical quality attribute definition, PPAP planning, Statistical analysis, CAD interpretation, GD&T, Root cause analysis
Preferred skills
ISO 13485, ISO 14971, Six Sigma, ASQ CSQE, Mistake Proofing/Poke Yoke, Tolerance analysis
Technologies
Minitab, CAD
Responsibilities
Partner with R&D to ensure mechanical product designs meet quality requirements; Lead risk management activities by developing plans and conducting reviews; Implement robust process controls for mechanical components; Participate in design reviews to track risk mitigation; Lead design validation activities including human factors evaluation; Support product design and quality transfers to manufacturing facilities; Analyze and define critical quality attributes through risk analysis; Contribute to final design verification and validation reports; Support PPAP planning and supplier approval.
Seniority
Staff, hands-on IC with strategic oversight
