Staff Design Quality Engineer
Core
Lead design quality for new hardware/software medical device development, sustaining product lines, and resolving customer quality issues.
Role type
Staff Design Quality Engineer (Medical Device)
Builds
Ultrasound imaging devices and AI/ML-enabled medical software
Domain
Medical device / Semiconductor / AI/ML
Deliverable
production ML models
Required skills
Design controls, Risk management (ISO 14971), 8D problem-solving, AI/ML validation, Human factors engineering, Cybersecurity, Electrical safety testing, QMS compliance (FDA 21 CFR Part 820, ISO 13485), SMT/PCBA manufacturing quality
Preferred skills
Experience with SaMD, clinical decision support tools, diagnostic algorithms, predictive models, IEC 62366, IEC 60601
Technologies
Ultrasound-on-Chip, AI/ML frameworks, Regulatory QMS tools
Responsibilities
Support regulatory and customer audits, advise cross-functional teams on design controls and risk mitigation, communicate quality metrics for continual improvement, maintain risk management files, resolve customer complaints and hardware failures
Seniority
Staff, hands-on IC with strategic oversight
