Product Safety Engineer
Core
Lead product safety and compliance for medical devices, ensuring regulatory adherence and quality throughout the product lifecycle.
Role type
Senior IC Product Safety Engineer
Builds
Respiratory care medical devices
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 60601 standards interpretation, ISO 80601 requirements, product safety testing, risk assessment, certification management, regulatory monitoring, cross-functional collaboration
Preferred skills
Electromagnetic compatibility testing, wireless compliance, AI tools in medical devices
Technologies
IEC 60601, ISO 80601
Responsibilities
Lead product safety and compliance activities for medical devices; interpret and apply safety standards to product designs; plan and execute safety testing and certification; support audits and maintain laboratory processes; monitor evolving regulations and assess impact on products
Seniority
Senior, hands-on IC