Senior System Engineer

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.