Software Safety Engineer

Location: London — hybrid, 3–4 days per week in the office Type: Full-time About The Role

• 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. The role
• 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. What You'll Do
• 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 Required What we're looking for
• 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 Preferred
• 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. How We Work The organisation provides independent, rigorous assessment, but doesn't see its role as simply being the “police”. Customers are treated as partners, with the aim of helping ambitious teams understand requirements, identify issues early and move through certification efficiently while maintaining the safety bar. The team values technical rigour, helpfulness and customer focus. It's a good environment for people who enjoy solving difficult problems, working directly with customers and moving quickly. Why join?
• Meaningful impact: Help assess technology that will ultimately be used by patients
• Technical depth: Work across software engineering, safety, regulation and AI
• Fast growth: Join a rapidly growing business expanding internationally
• Equity: Share in the value created as the business grows
• Global ambition: Work with an expanding international team
• Build, don't just operate: Shape assessment workflows, tools and processes
• Customer proximity: Work directly with ambitious companies building the next generation of medical devices Location
• This role is based in London and requires 3–4 days per week in the office.
• Regular office attendance is an important part of how the team works, and we're not able to offer a predominantly remote arrangement. Join the team
• This is an opportunity to help build a new model for medical device certification — one designed for a world where software and AI are advancing faster than traditional regulatory processes.