Senior Systems Engineer (Medical Devices)

Unicorn Resourcing; Greater London; Hybrid; GBP 70,000 - 75,000; Full time

Job summary

A leading medical technology business is seeking a Senior Systems Engineer to oversee the development and sustenance of innovative medical devices. The successful candidate will contribute to technology roadmaps and ensure compliance with regulatory standards. A Bachelor's degree in a relevant engineering field and experience in high-reliability systems are required. This hybrid role offers competitive compensation and opportunities for professional growth.

Qualifications

• Bachelor's degree or equivalent in appropriate engineering discipline.
• Experience with life-supporting systems like ventilators.
• Understanding of ISO / IEC / IEEE 15288 systems engineering lifecycle.

Responsibilities

• Specify, manage, and document system requirements.
• Develop system architecture and design.
• Lead governance activities and Critical Design Reviews.
• Ensure compliance with regulatory standards.
• Conduct risk management activities.
• Support knowledge transfer across teams.

Skills

Problem-solving skills in high-reliability systems

Experience applying ISO 14971 risk management

Requirements management

Knowledge of IEC standards

Collaboration and communication skills

Education

Bachelor's degree in Biomedical, Mechanical, Electrical, or Systems Engineering

Job description

Senior Systems Engineer (Medical Devices)

Location : Hybrid, head office in Croydon

Salary : £70-75k depending on experience

Hours : 37.5 hours a week (Monday - Friday)

The Opportunity

An exciting opportunity has arisen for a Senior Systems Engineer to join a leading medical technology business. This pivotal role is responsible for both new product development and product sustenance, ensuring the successful delivery of projects that meet business objectives in terms of scope, time, cost, quality, and performance.

As a key member of the R&D team, the Senior Systems Engineer will play a crucial role in shaping technology roadmaps, owning product architecture, and ensuring compliance with regulatory and performance standards.

Key Responsibilities

• Specify, manage, and document system requirements, including facilitation of user workshops.
• Develop and maintain system architecture and design in alignment with user and stakeholder needs.
• Lead engineering governance activities, including Critical Design Reviews (CDRs).
• Collaborate with verification and validation teams to support defect triage and resolution.
• Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks.
• Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews.
• Provide technical input, risk assessments, and continuous improvement recommendations during project meetings.
• Support knowledge transfer across teams, mentoring and sharing expertise.
• Contribute to the ongoing development and optimisation of engineering processes and tools.

Required Experience & Qualifications

• Bachelor’s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline.
• Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators).
• Demonstrated experience applying ISO 14971 risk management to medical device development.
• Strong knowledge of IEC standards for safety and performance in medical systems.
• Background in systems engineering disciplines: requirements management, architecture, V&V, and release.
• Proficiency in requirements engineering and risk analysis techniques across the device lifecycle.
• Strong understanding of ISO / IEC / IEEE 15288 systems engineering lifecycle within regulated environments.
• Experience working cross-functionally in multidisciplinary teams.

Desirable Skills

• Experience in R&D within regulated industries, ideally under ISO 13485 and IEC 60601.
• Knowledge of real-time control systems, control theory, and embedded platforms.
• Strong collaboration and communication skills, with enthusiasm for advancing medical technologies.

If you are interested in the role of Senior Systems Engineer and feel that you have the relevant experience, please contact your Recruitment Partner, Lisa Logan at Unicorn Resourcing on (phone number removed) or email (url removed)

If this job isn't exactly right for you but you're looking for something new, please contact us for a confidential career discussion.

Unicorn Resourcing Limited is acting as an Employment Agency in regard to this Permanent opportunity