Staff Design Quality Engineer (Software/Electrical)
Core
Provide on-site quality support for new product development of medical devices, ensuring designs meet safety and effectiveness requirements while partnering with R&D, Operations, and Regulatory teams.
Role type
Staff Design Quality Engineer (Software/Electrical)
Builds
Medical device products with integrated software and electrical systems
Domain
Medical device manufacturing and software engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management planning and execution, Design validation and verification, Human factors usability engineering, Supplier process control, PPAP planning and approval, Critical quality attribute definition, Change control processes, CAD drawing interpretation
Preferred skills
ISO 13485, ISO 14971, IEC-62304, Statistical analysis and process control, FMEA, GD&T, Root Cause Analysis, Mistake Proofing/Poke Yoke, Six Sigma, ASQ CSQE
Technologies
Minitab, CAD
Responsibilities
Partner with R&D to ensure product designs meet quality requirements for safety and effectiveness; Lead risk management activities by developing plans, conducting reviews, and verifying controls; Lead design validation activities including human factors usability engineering; 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 processes.
Seniority
Staff, hands-on IC with strategic oversight
