Senior Design Quality Engineer
Core
Provide quality engineering support for the design and development of medical device products, ensuring compliance with design controls, risk management, and change control processes.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Medical device products for Acute Care & Monitoring portfolio
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Risk Management (ISO 14971), Change Control, Verification/Validation planning, CAPA, Root cause failure analysis, EU-MDR regulations, IEC standards, ISO 13485
Preferred skills
Electronic/PCB design, Statistical analysis (Minitab, ANOVA), DFSS/Lean methodologies, HALT/HASS testing
Technologies
Minitab, Stat Graphics, IEC 60601
Responsibilities
Critically review product designs for impact on requirements and patient safety; Ensure design changes comply with QMS and regulations; Lead cross-functional teams to develop risk management files; Assist in creating and reviewing verification and validation test plans.
Seniority
Senior, hands-on IC
