Senior Systems Engineer

New Yesterday

A fast-growing medical technology company is seeking a Senior Systems Engineer to join its team at a state-of-the-art facility in Oxfordshire. This organisation is developing a next-generation implantable medical device platform aimed at addressing a significant unmet clinical need and it's a great time to be joining the business.
Role Overview
As a Senior Systems Engineer, you will be instrumental in shaping the architecture and documentation of complex medical systems. Youll work across software/firmware, hardware, and mechanical integration, supporting clinical trials and ensuring compliance with international standards.
Key Responsibilities
Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional teams including engineering, clinical, quality, and regulatory. Drive process improvements and stay current with evolving standards.
Skills & Experience
Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles.
Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners.
Whats on Offer
Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform.
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Location:
Cheltenham
Salary:
Hybrid working, Pension, Healthcare, £27 days annual leave, and more
Job Type:
FullTime
Category:
IT

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