Senior Systems Engineer
London, United Kingdom
Halian Technology Limited
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 ❯
Employment Type: Permanent
Posted: