Senior Software Quality Engineer
Core
Ensure software safety, reliability, and compliance throughout the medical device product development lifecycle.
Role type
Senior Software Quality Engineer (Medical Devices)
Builds
Safe and compliant medical device software products
Domain
Healthcare technology / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software development lifecycle management, requirements traceability, verification and validation, risk management (SFMEA, hazard analysis), defect investigation, root cause analysis, CAPA, configuration management, regulatory compliance knowledge
Preferred skills
Medical device software experience, embedded software knowledge, cybersecurity evaluation, audit support, Agile methodology
Technologies
ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, IEC 60601-1
Responsibilities
Support software quality activities from requirements to post-market support, collaborate on design reviews and technical architecture, execute verification and validation plans, manage risk mitigation activities, support internal/external audits, drive process improvements based on quality metrics
Seniority
Senior, hands-on IC
