Software Safety Engineer

About the role

WE PULL MEDICAL TECHNOLOGY FROM THE FUTURE TO SOLVE HUMAN HEALTH.

Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

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.

ABOUT THE ROLE

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 Scarlet can reach rigorous certification decisions about medical device software and help safe devices reach patients sooner.

RESPONSIBILITIES

- 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 Scarlet'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

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, 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

PREFERRED QUALIFICATIONS

- 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

INTERVIEW PROCESS

1. Intro call with Hann https://www.linkedin.com/in/hann-yee-son-26101624a/ — 30 mins

2. Interview with one of our Software Safety Engineers — 30 mins