Role summary
Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.
Responsibilities
As a Software Safety Engineer, you’ll assess software lifecycle processes and technical documentation for medical device software. You’ll use AI-assisted workflows to navigate evidence, explore failure modes, develop questions and test hypotheses, and surface inconsistencies for deeper review. You’ll experiment with improvements to your workflows as model capabilities improve and work with our product, engineering and applied machine learning teams to improve the tools you use. Your work will identify software risks and evidence gaps so the organization can reach rigorous certification decisions about medical device software and help safe devices reach patients sooner.
- Assess software lifecycle processes and technical documentation submitted by our customers
- Screen and action regulatory insights from the latest research, standards and guidance
- Work with our product, engineering and applied machine learning teams to improve our systems
- Work with our market access team to expand the organization's responsibility to new jurisdictions and certifications
- Create content to explain complex regulatory topics to customers and prospects
- Provide regulatory insights to prospects and customers
Requirements
- A degree in computer science or a related discipline
- Four or more years’ experience in medical device or other safety-critical product manufacturing, auditing or research, including two or more years’ experience developing safety-critical software
- Practical experience with software development fundamentals, including software development lifecycle processes, software verification and validation testing, software configuration management and cybersecurity
- Exceptional written and verbal communication skills
Nice to have
- Knowledge or training in the relevant standards and guidance for medical device software, such as IEC 62304 and IEC 81001-5-1
- Practical experience with generative AI e.g. LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring
- Intro call with Hann — 30 mins
- Interview with one of our Software Safety Engineers — 30 mins
- Technical task and interview with Hann — 1 hour
- Culture and values interviews with Sandy, James and Jamie — 30 mins each
- Referencing and offer
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Standards
- IEC 62304