Principal Engineer, Software Quality
Core
Define, implement, and execute robust quality assurance processes and strategies for medical device software throughout the SDLC to ensure safety, reliability, and regulatory compliance.
Role type
Principal Software Quality Engineer (Medical Devices)
Builds
Safe and effective medical device software products
Domain
Medical Technology / Regulated Software Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software Quality Assurance strategy, Risk management (ISO 14971, IEC 62304), Regulatory compliance (FDA 21 CFR Part 820, ISO 13485), Test plan and case design, Defect management, Root cause analysis, Audit preparation, Technical leadership
Preferred skills
Polarion ALM, Embedded/Cloud testing, CCB facilitation
Technologies
Polarion ALM, FDA 21 CFR Part 820, ISO 13485, IEC 62304
Responsibilities
Develop and maintain QA strategies aligned with industry best practices and regulations; Lead review of test plans, cases, and automation scripts for complex software systems; Develop risk management files and perform risk analysis; Lead defect management and CCB meetings; Conduct design and code reviews to identify quality issues; Perform root cause analysis and drive corrective actions; Participate in internal and external audits; Mentor junior quality engineers.
Seniority
Principal, hands-on IC with strategic oversight
