2 of 2 IEC 62304 Jobs in London

system architecture and solving complex technical issues. Manage a growing team by conducting effective 1:1s, coach engineers, lead hiring and onboarding, and manage a career development framework. Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits. Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA … in a fast-paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and … delivery, while adapting to evolving needs What success looks like: 3 months: Define team rituals that promote alignment, speed, and predictability Deliver traceability and documentation gap analysis aligned to IEC 62304 6 months: Lead release of a major AI model or SaMD milestone on time Identify and implement 3 delivery optimisations that improve speed without sacrificing quality More ❯

including Critical Design Reviews (CDRs). 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 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 15288 lifecycle within regulated product development. Comfortable working in cross-functional … teams and dynamic project environments. Desirable: Experience in ISO 13485-compliant environments. Knowledge of real-time control systems and embedded platforms. Experience in IEC 62304 Strong communication and collaboration skills across engineering, quality, and clinical teams. More ❯