Senior Systems Engineer

Walker Cole International is supporting a leading medical device organisation in the search for a Senior Systems Engineer to join their R&D team focused on the development of complex, high-reliability medical device systems.

This role will support both new product development and product sustenance activities, with responsibility for systems architecture, requirements management, risk analysis, and regulatory compliance across the full product lifecycle. Candidates with experience in ventilators, life-supporting systems, or regulated medical device environments are highly desirable.

This is a 6-month contract paying a competitive daily rate outside of IR35.

Key Responsibilities

• Define, specify, and manage system requirements, including facilitation of user and stakeholder workshops.
• Develop and maintain system architecture and system-level design aligned with technical, regulatory, and user requirements.
• Generate and maintain engineering documentation to support downstream development activities.
• Lead and contribute to engineering governance activities including Critical Design Reviews (CDRs).
• Support Verification & Validation activities including defect triage, issue resolution, and systems assurance.
• Conduct risk management activities including FMEA and hazard analysis in accordance with ISO 14971.
• Perform gap analyses against standards such as IEC 60601 and support ongoing compliance activities.
• Contribute to technology roadmaps, engineering process improvements, and continuous improvement initiatives.
• Collaborate across multidisciplinary teams including Engineering, Quality, Regulatory, and Clinical functions.

Required Experience & Skills

• Degree qualified in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
• Strong systems engineering experience within regulated medical device or high-reliability product development environments.
• Experience applying ISO 14971 risk management processes within medical device development.
• Strong understanding of IEC 60601-1 and medical device safety/performance requirements.
• Experience across core systems engineering disciplines including requirements management, architecture definition, verification & validation, and product release.
• Understanding of the systems engineering lifecycle in accordance with ISO/IEC/IEEE 15288.
• Experience working within cross-functional, fast-paced R&D environments.

Desirable Experience

• Experience within ventilators or life-supporting medical systems.
• Knowledge of ISO 13485, IEC 62304, and embedded or real-time control systems.
• Strong communication and stakeholder management skills with a collaborative approach to problem solving.

Location: London (3 days on-site, 2 WFH)
Length: 6 Months
Rate: Competitive day rate (DOE) 
Job ID: 106404