AI-Powered Medical Device 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

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