Lead QA Engineer - Medical Device Embedded Software Testing

Hydrogen Group; Motherwell; Hybrid; GBP 73,000 - 122,000; Full time

Job summary

Hydrogen Group is seeking a Lead QA Engineer to lead embedded software testing for a medical device used in diagnostics and patient monitoring. The role focuses on hands-on testing, documenting V&V evidence and ensuring compliance for FDA 510(k) submissions.

The contract is a 3-month initial engagement, hybrid in Motherwell, Scotland, with flexible onsite requirements and a strong emphasis on risk management, regulatory deadlines, and reliable defect resolution.

Qualifications

• Write and execute test cases against embedded medical-device software.
• Produce documented verification and validation evidence.
• Report, investigate and manage software defects through to resolution.
• Contribute to impact analysis, risk analysis and FMEAs.
• Support regulatory submission and commercial release deadlines.
• Personally writing and executing tests for software embedded within a medical device.
• Medical-device software V&V within a regulated development environment.
• Documenting test results and linking evidence to requirements.
• Risk‑based testing and contribution to risk-management activities.
• Leading testing activities while remaining hands‑on.
• Experience supporting an FDA 510(k) submission is highly desirable.

Responsibilities

• Write and execute test cases against embedded medical-device software.
• Produce documented verification and validation evidence.
• Report, investigate and manage software defects through to resolution.
• Contribute to impact analysis, risk analysis and FMEAs.
• Support regulatory submission and commercial release deadlines.
• Personally writing and executing tests for software embedded within a medical device.
• Medical-device software V&V within a regulated development environment.

Skills

Embedded software testing

Medical device testing

V&V

Risk analysis

FMEA

Job description

Lead QA Engineer - Medical Device Embedded Software Testing

Up to £660/day | Inside IR35 | Hybrid - Motherwell, Scotland

Previous hands-on experience testing embedded software within medical devices is essential. We can only consider candidates who meet this requirement.

This is a specialist device-software testing contract. General web/application QA, pharmaceutical Computer Systems Validation (CSV), manufacturing validation or quality management experience alone will not meet the brief.

You’ll lead and execute software testing for a standalone medical device used for diagnostics and patient monitoring, delivering V&V evidence for an FDA 510(k) submission and a subsequent commercial software release.

Location flexibility

• Within an hour of Motherwell: 2 days per week onsite.
• Further away: 2-3 days per month onsite may be agreed for the right candidate.
• Rate: Up to £663/day, Inside IR35
• Start: 1 October
• Duration: 3 months initially, with a further period of at least 12 months anticipated

What you’ll do

• Write and execute test cases against embedded medical-device software.
• Produce documented verification and validation evidence.
• Report, investigate and manage software defects through to resolution.
• Contribute to impact analysis, risk analysis and FMEAs.
• Support regulatory submission and commercial release deadlines.
• Personally writing and executing tests for software embedded within a medical device.
• Medical-device software V&V within a regulated development environment.
• Documenting test results and linking evidence to requirements.
• Risk‑based testing and contribution to risk‑management activities.
• Leading testing activities while remaining hands‑on.

Experience supporting an FDA 510(k) submission is highly desirable.