Software Safety Engineer

About the role

Scarlet assesses and certifies medical devices, combining clinical, technical and regulatory expertise with AI. As a Software Safety Engineer you will evaluate software lifecycle processes and technical documentation for medical device software, using AI‑assisted workflows to identify risks and evidence gaps. Your work will help ensure rigorous certification decisions and accelerate safe device delivery to patients.

Key responsibilities

• Assess software lifecycle processes and technical documentation submitted by customers.
• Screen and act on regulatory insights from the latest research, standards and guidance.
• Collaborate with product, engineering and applied‑machine‑learning teams to improve internal systems.
• Work with the market access team to expand Scarlet’s responsibilities to new jurisdictions and certifications.
• Create content that explains complex regulatory topics to customers and prospects.
• Provide regulatory insights to prospects and customers.

Required profile

• A degree in computer science or a related discipline.
• Four or more years of experience in medical device or other safety‑critical product manufacturing, auditing or research, including at least two years developing safety‑critical software.

Required skills

• Software development lifecycle processes.
• Software verification and validation testing.
• Software configuration management.
• Cybersecurity.
• Knowledge of IEC 62304 and IEC 81001‑5‑1 standards.
• Experience with generative AI technologies such as LLMs, embeddings, RAG, fine‑tuning, evaluation and monitoring.