Principal Software Design Quality Engineer - Cardiac Rhythm Management & Diagnostics
Core
Lead design controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory compliance for active implantable medical devices.
Role type
Principal Software Design Quality Engineer
Builds
Active implantable medical devices (Cardiac Rhythm Management & Diagnostics)
Domain
Medical Devices / Healthcare
Required skills
ISO 14971 risk management, software V&V, cybersecurity integration, regulatory compliance, statistical validation techniques, technical documentation, Design History File management, hazard analysis, FMEA, traceability management
Preferred skills
Cross-functional leadership, mentoring engineers, post-market surveillance, design change analysis
Technologies
ISO 14971, FMEA, Design History File, Design Input/Output documentation
Responsibilities
Lead software design quality for strategic product development initiatives; drive implementation of risk management processes and tools; collaborate with cybersecurity teams for compliance; apply systematic problem-solving for quality issues; support verification, validation, and usability testing; maintain Design History File and technical documentation; participate in design change processes; support post-market activities.
Seniority
Principal, strategy & mentorship