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.

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