2 of 2 Permanent ISO 13485 Jobs in London

teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical … mechanical, electrical, or systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE ...

following would be a bonus: Skills in containerisation/orchestration (Docker, Kubernetes etc.); IaC; DynamoDB; Spring Boot and Gradle; knowledge of standards such as ISO 13485 or IEC 62304. This role is predominantly remote, with occasional attendance of the company's London office - you will therefore need ...