Senior Design Quality Engineer (Software/Electrical)
Core
Provide quality support for new product development of software and electrical medical devices, partnering with cross-functional teams on design verification, validation, risk management, and cybersecurity.
Role type
Senior Design Quality Engineer (Software/Electrical)
Builds
Medical acute care devices and systems
Domain
Medical device manufacturing / Software and Electrical Engineering
Required skills
Risk management (ISO 14971), Design verification and validation, Cybersecurity implementation, Process controls, PPAP planning, FMEA, Root Cause Analysis, Mistake Proofing, Statistical process control, Reading electrical schematics
Preferred skills
Six Sigma certification, ASQ certification, ISO 13485 knowledge, Human factors usability engineering, Data analysis, Master's degree in engineering
Technologies
Minitab, ISO 13485, ISO 14971
Responsibilities
Partner with R&D to ensure designs meet safety and reliability requirements; Lead risk management activities and reviews; Implement cybersecurity best practices; Lead design validation including human factors; Support design verification planning and execution; Support product design transfers to manufacturing; Analyze critical quality attributes; Partner with suppliers on process controls; Support PPAP planning and approval.
Seniority
Senior, hands-on IC