Senior System Verification Engineer (Medical Device)
Core
Own system-level verification activities for medical device systems across the product lifecycle, ensuring compliance with standards and regulatory requirements.
Role type
Senior System Verification Engineer (Medical Device)
Builds
Medical device systems (scanning technology) for preventative health care
Domain
Healthcare technology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System-level verification and validation, Embedded systems testing (hardware/firmware/software), Regulatory compliance translation, Test automation, Traceability matrix management, Test reporting
Preferred skills
IEC 60601 series standards expertise, FDA/MDR/ISO 14971 framework knowledge, External test house coordination
Technologies
IEC 60601 series, FDA, MDR, ISO 14971
Responsibilities
Partner with design engineers to ensure compliance with standards and regulatory requirements from concept to industrialization; Translate regulatory requirements into actionable guidance for design decisions; Influence product requirements to ensure they are testable and traceable; Develop efficient verification methodologies, tools, and workflows for end-to-end and regression testing; Coordinate with external test houses for specialized testing (EMC, electrical safety, environmental); Ensure continuity of test requirements through design transfer; Create comprehensive test reports and communicate findings; Contribute to traceability matrices and drive continuous improvement of verification processes
Seniority
Senior, hands-on IC