Medical Software Safety Engineer

Computer Futures / SThree Group; Greater London; Hybrid; GBP 77,000 - 94,000; Full time

Benefits offered by this job

Share option scheme

Hybrid work flexibility

Job summary

Computer Futures / SThree Group is seeking a Software Safety Engineer to drive software safety across the product lifecycle for medical devices. You will perform hazard analyses, risk assessments, and prepare safety documentation, collaborating with Software, Quality, Regulatory and Product Development teams.

The role requires 4 years in medical devices or SaMD, deep knowledge of ISO 14971 and IEC 62304, and a proactive approach to risk management.

Qualifications

• 4 years of experience in the medical device and/or SaMD sector.
• Strong understanding of software risk management and functional safety.
• Knowledge of ISO 14971, IEC 62304 and related medical device regulations.

Responsibilities

• Drive software safety activities throughout the product lifecycle.
• Conduct hazard analysis, risk assessments, and safety documentation.
• Collaborate with cross-functional teams including Software, Quality, Regulatory and Product Development.
• Ensure compliance with relevant medical device standards and regulatory requirements.
• Support verification, validation and software risk management activities.

Skills

Software safety engineering

Software risk management

Functional safety standards

Job description

We're partnering with an innovative medical technology consultancy looking for a Software Safety Engineer to support high-quality software-based medical devices.

Key Responsibilities

• Drive software safety activities throughout the product lifecycle.
• Conduct hazard analysis, risk assessments, and safety documentation.
• Collaborate with cross-functional teams including Software, Quality, Regulatory, and Product Development.
• Ensure compliance with relevant medical device standards and regulatory requirements.
• Support verification, validation, and software risk management activities.

Requirements

• 4 years of experience within the medical device and/or Software as a Medical Device (SaMD) sector.
• Strong understanding of software risk management and functional safety principles.
• Knowledge of standards such as ISO 14971, IEC 62304, and related medical device regulations.

What's on Offer

• Up to £85,000
• Share option scheme
• Potential hybrid flexibility