Software Safety Engineer

The role

You will assess software lifecycle processes and technical documentation for medical device software. You will use AI-assisted workflows to navigate evidence, explore failure modes, and identify software risks.

What you will do

• Assess software lifecycle processes and technical documentation submitted by customers
• Screen and action regulatory insights from research, standards and guidance
• Work with product, engineering and applied machine learning teams to improve systems
• Work with market access team to expand responsibility to new jurisdictions and certifications
• Create content to explain complex regulatory topics to customers and prospects
• Provide regulatory insights to prospects and customers

Required qualifications

• 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
• Two or more years experience developing safety-critical software
• Practical experience with software development fundamentals
• Experience with software development lifecycle processes
• Experience with software verification and validation testing
• Experience with software configuration management
• Experience with 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

Before you apply

• Intro call with Hann
• Interview with one of our Software Safety Engineers
• Technical task and interview with Hann
• Culture and values interviews with Sandy, James and Jamie
• Offer and referencing

About the company

Scarlet is authorised to assess and certify medical devices. They combine clinical, technical and regulatory expertise with AI agents and software.