Senior Systems Engineer
Oxfordshire, South East, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
Halian Technology Limited
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 … 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 More ❯
Employment Type: Permanent, Work From Home
Salary: Hybrid working, Pension, Healthcare, 27 days annual leave, and more
Posted: