Compliance Engineer, Product Safety & Compliance
Core
Ensure global product safety and regulatory compliance for Sleep & Respiratory Care medical devices through testing, design reviews, and certification management.
Role type
Product Safety & Compliance Engineer
Builds
Medical device products (Sleep & Respiratory Care technologies)
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Medical device safety standards (IEC 60601, ISO 80601), product safety testing, regulatory agency reporting, test plan development, equipment operation (power meters, oscilloscopes, environmental chambers), emerging regulation analysis, supplier liaison
Preferred skills
Electromagnetic compatibility testing, wireless compliance, respiratory medical devices, AI tools
Technologies
Power meters, power analyzers, data loggers, spectrum analyzers, oscilloscopes, dielectric strength testers, ground continuity testers, digital multi-meters, surge generators, over-voltage testers, environmental condition chambers
Responsibilities
Perform tests to comply with global product safety standards; complete preliminary design reviews and develop test plans; compile test results and submit reports to regulatory agencies; review emerging regulations and propose compliance plans; interface with certification agencies for site inspections; liaise with external testing suppliers; assist product development in maintaining compliance data
Seniority
Mid-level, hands-on IC