Principal System Engineer

Halian | Managed Services, Recruitment Agency & Contract Staffing; England; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading recruitment agency is seeking a Principal Systems Engineer for a major medical device company in London. This role involves leading technical architecture, driving engineering governance, and ensuring compliance with industry standards. Candidates should have a relevant engineering degree and experience in high-reliability systems, with a strong understanding of ISO and IEC standards. This position offers a unique opportunity to impact life-supporting technology development within an innovative R&D environment.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, or systems engineering (or equivalent).
• Strong background in high-reliability systems.
• Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release.

Responsibilities

• Lead the definition and execution of technology roadmaps aligned with long-term business goals.
• Own system architecture and feasibility assessments for assigned products.
• Drive engineering governance activities, including Critical Design Reviews (CDRs).

Skills

ISO 14971 knowledge

Understanding of IEC 62304

Systems engineering

Cross-functional collaboration

Risk management

Education

Bachelor’s degree in engineering

Job description

Halian is proud to partner with a leading medical device company based in London in their search for a Principal 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 Principal Systems Engineer, you’ll be at the forefront of shaping technical architecture, optimising engineering processes, and ensuring regulatory compliance across complex systems. 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.