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 Devices)
Builds
Ultrasound imaging devices, AI/ML-enabled medical devices, and semiconductor-based sensing hardware
Domain
Medical device industry, Ultrasound imaging, AI/ML in healthcare
Deliverable
production ML models
Required skills
Design controls, Risk management (ISO 14971), 8D problem-solving, Human factors/usability engineering (IEC 62366), AI/ML validation for SaMD, Cybersecurity risk assessment, Electrical safety testing (IEC 60601), QMS compliance (FDA 21 CFR Part 820, ISO 13485), SMT/PCBA manufacturing quality
Preferred skills
Experience with Butterfly Network's Ultrasound-on-Chip technology, Semiconductor industry background
Technologies
Ultrasound-on-Chip™, Compass AI™, Butterfly Garden™ SDK
Responsibilities
Support regulatory audits (FDA, notified body), advise cross-functional teams on design controls and AI/ML considerations, communicate quality metrics for continual improvement, maintain risk management files, resolve customer complaints and hardware failures
Seniority
Staff, hands-on IC with strategic cross-functional leadership
