Senior System Engineer
3 days ago
City of London
Halian is proud to partner with a leading medical device innovator based in London in their search for a Senior Systems Engineer. This is a pivotal role within the growing R&D team, driving both new product development and sustaining engineering for life-supporting technologies. As a Senior Systems Engineer, you’ll be at the forefront of shaping technical architecture, optimising engineering processes, and ensuring regulatory compliance across complex systems within Medical Devices. This is a fantastic opportunity to make a tangible impact in a regulated, high-reliability environment. Key Responsibilities: • Lead the definition and execution of technology roadmaps aligned with long-term business goals., • Own system architecture and feasibility assessments for assigned products., • Translate stakeholder needs into robust system requirements and design documentation., • Drive engineering governance activities 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, IEC 62304, and ISO 14971., • Conduct risk management activities including FMEA and hazard analysis., • Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications: Essential: • Bachelor’s degree in biomedical, mechanical, electrical, or systems engineering (or equivalent)., • Strong background in high-reliability systems., • Deep understanding of ISO 14971 and IEC 62304 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 60601-1, • Strong communication and collaboration skills across engineering, quality, and clinical teams.