Software Safety Engineer

About this role

Assess medical-device software lifecycle processes and technical documentation to identify safety risks and evidence gaps. Use AI-assisted workflows to support rigorous certification decisions, and collaborate with product, engineering, and machine-learning teams to improve the tools and expand regulatory coverage.

About the company

Scarlet is a notified body that certifies AI and software medical devices under EU MDR and UK MDR without unnecessary delays.

The team

Devices and Software teams

What you'll do

• Assess customer software lifecycle processes and technical documentation
• Track and act on regulatory research, standards, and guidance
• Work with product, engineering, and applied machine-learning teams to improve systems
• Support expansion into new jurisdictions and certifications
• Create customer-facing content explaining regulatory topics
• Provide regulatory insights to customers and prospects

What we're looking for

• Degree in computer science or a related discipline
• At least 4 years’ experience in medical-device or other safety-critical product manufacturing, auditing, or research
• At least 2 years’ experience developing safety-critical software
• Practical knowledge of software development lifecycle processes, verification and validation testing, configuration management, and cybersecurity
• Exceptional written and verbal communication skills

Nice to have

• Knowledge or training in IEC 62304 and IEC 81001-5-1
• Practical experience with generative AI, such as LLMs, embeddings, RAG, fine-tuning, evaluation, or monitoring

Benefits

• Equity

Hiring process

1. 30-minute introductory call
2. 30-minute interview with a Software Safety Engineer
3. Technical task and 1-hour interview
4. Three 20-minute culture and values interviews
5. Offer and referencing