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# Senior System Engineer

- **Company:** Halian .
- **Location:** Greater London, UK
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Failure Mode Effects Analysis, Software Tools, Software Requirements Analysis, Systems Architecture
- **Published:** September 9, 2026
- **Apply:** https://www.collegerecruiter.com/job/2850544916-senior-system-engineer

## About the Role

* Bachelor's degree in biomedical, mechanical, electrical, or systems engineering (or equivalent).
 * Strong background in high-reliability systems.
 * Deep understanding of ISO 14971 and IEC 62304 standards.
 * Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release.
 * Familiarity with ISO/IEC/IEEE 15288 lifecycle within regulated product development.
 * Comfortable working in cross-functional teams and dynamic project environments.
 * Experience in ISO 13485-compliant environments.
 * Knowledge of real-time control systems and embedded platforms.
 * Experience in IEC 60601-1
 * Strong communication and collaboration skills across engineering, quality, and clinical teams.

## Description

As a Senior Systems Engineer, you'll be at the forefront of shaping technical architecture, optimising engineering processes, and ensuring regulatory compliance across complex systems. This is a fantastic opportunity to make a tangible impact in a regulated, high-reliability environment., * Lead the definition and execution of technology roadmaps aligned with long-term business goals.

 * Own system architecture and feasibility assessments for assigned products.
 * Translate stakeholder needs into robust system requirements and design documentation.
 * Drive engineering governance activities, including Critical Design Reviews (CDRs).
 * Collaborate with V&V teams to support defect triage, issue resolution, and validation.
 * Monitor regulatory changes and ensure compliance with standards such as IEC 60601, IEC 62304, and ISO 14971.
 * Conduct risk management activities, including FMEA and hazard analysis.
 * Champion continuous improvement across engineering tools and processes.


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