Senior System Engineer

Halian | Managed Services, Recruitment Agency & Contract Staffing; Greater London; On-site; GBP 70,000 - 110,000; Full time

Job summary

Halian, in partnership with a leading medical device company based in London, seeks a Senior Systems Engineer. You will shape technical architecture, drive roadmaps, and ensure high-reliability design for life-supporting technologies within a regulated environment.

You’ll collaborate with V&V and quality teams to meet IEC 60601, IEC 62304, ISO 14971, ISO 13485, and 15288 standards, lead CDRs, manage risks with FMEA, and translate stakeholder needs into robust requirements.

Qualifications

• 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.
• 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.

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.

Skills

High-reliability systems

ISO 14971

IEC 62304

Requirements engineering

System architecture

V&V

ISO 13485 environment

IEC 60601-1

ISO/IEC/IEEE 15288

Cross-functional collaboration

Education

Bachelor’s degree in biomedical, mechanical, electrical, or systems engineering

Job description

Halian is proud to partner with a leading medical device company 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. 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:

• 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.
• 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.