Role summary
As Software Safety Engineer, you'll assess software lifecycle processes and technical documentation from customers, using AI assisted workflows to work through evidence, test hypotheses and surface inconsistencies for review. You'll work closely with product, engineering and applied machine learning colleagues to keep sharpening those tools, support the market access team as the business expands into new jurisdictions, and help explain complex regulatory topics clearly to customers and prospects.
Requirements
- A degree in computer science or a related discipline
- Four or more years in medical device or other safety critical manufacturing, auditing or research, including two or more years developing safety critical software
- Solid grounding in software development lifecycle processes, verification and validation testing, configuration management and cybersecurity
- Excellent written and verbal communication skills
Nice to have
- Knowledge of relevant standards such as IEC 62304 and IEC 81001 5 1
- Hands on experience with generative AI, LLMs, embeddings, RAG, fine tuning or evaluation and monitoring
If you want to be right in the thick of where healthcare, hard engineering and artificial intelligence meet, I'd love to hear from you.
Standards
- IEC 62304 Medical Device Software - Software Life Cycle Processes