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