2 of 2 IEC 62304 Jobs in London

documentation, and cross-functional collaboration skills. Strong root-cause analysis skills across electro-mechanical and instrument systems. Experience applying standards such as ISO 13485, IEC 62304, 21 CFR 820, IVDR, IEC 62366. Familiarity with ISO 14971 risk management (FMEA, FTA etc.). Broad engineering understanding (mechanical systems ...

. Collaborate with V&V 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 … 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 ...