8 of 8 ISO 13485 Jobs in London

technical strategy. Develop novel approaches to overcome product development challenges. Maintain quality records across chemistry, consumables, and instrument activities. Ensure documentation complies with ISO 13485 requirements in collaboration with Quality. About You You ll bring a strong background in systems engineering within IVD, diagnostics or closely regulated medical … Excellent communication, 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 ...

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 ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

management (FMEA, hazard analysis) and V&V. Key skills: + Strong knowledge of systems engineering lifecycle. + Skilled in risk management and regulatory compliance ISO 14971 + Experience of R&D in a regulated environment, ISO 13485 would be beneficial. The salary will ...