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Halian | Managed Services, Recruitment Agency & Contract Staffing

Senior System Engineer

London
Posted about 20 hours ago
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Halian is proud to partner with a leading medical device company based in London in their search for a Senior 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 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.

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.

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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.

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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.
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Skills

Systems Engineering
Technical Architecture
Regulatory Compliance
Risk Management
ISO 14971
IEC 62304
IEC 60601
FMEA
V&V
Requirements Engineering
Design Documentation
Hazard Analysis
ISO 13485
Embedded Platforms
Real-time Control Systems
Engineering Governance

Location

London, England, United Kingdom

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