Software Safety Engineer

• We’re working with a fast-growing organisation building a new approach to medical device certification.
• The team combines clinical, technical and regulatory expertise with AI and software to help rigorous certification keep pace with product development at some of the world’s most ambitious technology companies — without lowering the safety bar.
• Its customers are developing innovative healthcare technology, including AI-enabled medical devices, clinical decision-support tools, digital therapeutics and other software-led products.
• The business has grown rapidly, recently raised a Series B and is approaching 100 customers, with international expansion underway. This is an opportunity to join while there is still a huge amount to build.

• As a Software Safety Engineer, you’ll sit within the assessment team, assessing the software safety of medical devices as part of quality management and certification work.
• You’ll bring a strong background in software engineering, testing and safety-critical development to assess customers’ products and processes. You’ll review software lifecycle processes and technical documentation, identify risks and evidence gaps, explore failure modes and contribute to rigorous certification decisions.
• You’ll also use and help shape AI-assisted workflows to navigate evidence, develop questions, test hypotheses and surface inconsistencies for deeper review. You’ll work closely with product, engineering and applied machine learning teams to improve these tools as AI capabilities evolve.
• The goal is simple: help safe medical technology reach patients faster, without compromising the safety bar.

• Assess software lifecycle processes and technical documentation
• Evaluate software safety, risks, gaps and inconsistencies in technical evidence
• Review software verification and validation activities and supporting evidence
• Apply your software engineering and safety-critical experience to certification assessments
• Monitor and act on regulatory insights from research, standards and guidance
• Use AI-assisted tools to investigate evidence, explore failure modes and develop assessment questions
  
  Work with product, engineering and machine learning teams to improve assessment workflows
• Contribute to expanding into new jurisdictions and certification frameworks
• Create clear content explaining complex technical and regulatory topics
• Provide technical and regulatory insight to customers throughout certification

• Degree in computer science or a related discipline
• 4+ years’ experience in medical device or another safety-critical product environment, including manufacturing, auditing or research
• 2+ years’ experience developing safety-critical software
• Practical experience with:
• Software development lifecycle processes
• Software verification and validation testing
• Software configuration management
• Cybersecurity
• Strong technical judgement and the ability to understand complex software systems and identify meaningful safety risks
• Excellent written and verbal communication skills

• Knowledge or formal training in relevant medical device software standards, such as IEC 62304 and IEC 81001-5-1
• Experience with medical device software certification, assessment, auditing or regulatory processes
• Experience with generative AI, including LLMs, embeddings, RAG, fine-tuning, evaluation or monitoring

You don’t need experience in every area above. We’re particularly interested in people with a strong software engineering and safety‑critical background who are excited to apply that expertise in a rapidly evolving environment.

The organisation provides…