Software Safety Engineer

KO2 Embedded Recruitment Solutions Ltd; Greater London; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

KO2 Embedded Recruitment Solutions Ltd is partnering with a leading authority to certify AI powered medical devices in a fast moving environment. The Software Safety Engineer will assess software lifecycle processes and regulatory documentation from customers, using AI assisted workflows to surface inconsistencies for review.

You'll work closely with product, engineering and applied machine learning colleagues to sharpen these tools, support the market access team as the business expands into

Qualifications

• Degree in computer science or related discipline.
• 4+ years in medical device or safety-critical field, with 2+ years developing safety-critical software.
• Solid grounding in software lifecycle processes, verification & validation, configuration management and cybersecurity.
• Excellent written and verbal communication skills.

Responsibilities

• Assess software lifecycle processes and technical documentation from customers using AI assisted workflows to surface inconsistencies for review.
• Collaborate with product, engineering and applied ML colleagues to sharpen tools.
• Support market access as the business expands into new jurisdictions.
• Explain complex regulatory topics clearly to customers and prospects.

Skills

Software lifecycle

Verification & Validation

Cybersecurity basics

Excellent communication

Education

Degree in Computer Science or related discipline

Tools

IEC 62304

IEC 81001-5-1

AI safety tooling

Job description

Software Safety Engineer — AI Powered Medical Device Certification

Location: Central London, hybrid working

Fancy working somewhere that's properly rewriting how medical devices get certified as safe? My client holds the authority to formally assess and certify medical devices, and rather than doing it the slow way, they pair experienced clinical, technical and regulatory minds with AI agents and purpose built software, so certification can keep pace with genuinely cutting edge product development, AI enabled diagnostics and robotic assisted devices included, without ever loosening the safety bar. The result is safe technology reaching patients a good deal quicker than the industry is used to.

As Software Safety Engineer, you'll assess software lifecycle processes and technical documentation from customers, using AI assisted workflows to work through evidence, test hypotheses and surface inconsistencies for review. You'll work closely with product, engineering and applied machine learning colleagues to keep sharpening those tools, support the market access team as the business expands into new jurisdictions, and help explain complex regulatory topics clearly to customers and prospects.

What you'll need

• A degree in computer science or a related discipline
• Four or more years in medical device or other safety critical manufacturing, auditing or research, including two or more years developing safety critical software
• Solid grounding in software development lifecycle processes, verification and validation testing, configuration management and cybersecurity
• Excellent written and verbal communication skills

Nice to have

• Knowledge of relevant standards such as IEC 62304 and IEC 81001 5 1
• Hands on experience with generative AI, LLMs, embeddings, RAG, fine tuning or evaluation and monitoring

If you want to be right in the thick of where healthcare, hard engineering and artificial intelligence meet, I'd love to hear from you.