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System Safety Engineer (IEC 62304)

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StageDirectory listedStandardsIEC 62304 · ISO 14971 · IEC 60601IndustryMedicalSeniorityMid-levelRegionUnited KingdomWork modeHybridSource year2026Role familySystems safetySegmentOtherEmployerEmployer profileClearanceMentioned
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Role summary

You'll belong to a central safety practice for your technical home and development, but work day-to-day as a trusted, embedded partner inside a delivery team — holding agility and compliance together rather than treating them as opposites.

Responsibilities

  • Building a proportionate, risk-based safety approach tailored to actual risk, not a fixed checklist
  • Owning design safety artefacts (FHA, FMECA, CCA, PSSA/SSA) to a standard fit for regulatory scrutiny
  • Tracking your programme's safety case end-to-end, flagging risk early
  • Working closely with design and test teams, assessing safety impact of changes in real time
  • Acting as the safety voice within a cross-disciplinary engineering team
  • Solid grounding in system safety techniques and reasoning, with working knowledge of the relevant UK/international regulatory landscape
  • Familiarity with software/complex electronic hardware safety assurance
  • ~10 years' experience for Senior, ~15+ for Principal — though exceptional pedigree with less time served is equally welcome
  • Eligibility for UK security clearance
  • Willingness to travel occasionally internationally

Standards

  • IEC 62304
  • ISO 14971
  • IEC 60601

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