Halian is proud to partner with a leading medical device company based in London in their search for a Principal Systems Engineer. This is a pivotal role within the growing R&D team, driving both new product development and sustaining engineering for life-supporting technologies.
As a Principal 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.
Key Responsibilities:
* 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.
Required Experience & Qualifications:
Essential:
* 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.
Desirable:
* 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.