2 of 2 FMEA Jobs in London

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 ...

and EU MDR submission with software-related technical documentation Work within an ISO 13485 QMS framework and contribute to design FMEA, traceability, and risk management processes Leadership & Team Building Contribute to the product roadmap and technical strategy alongside the CTO Help define the engineering team structure and hiring plan ...