Lead QA Engineer – Medical Device Embedded Software Testing

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

Job summary

Hydrogen UK Ltd is seeking a Lead QA Engineer to oversee testing of embedded medical-device software in a hybrid role based near Motherwell, Scotland. You will lead hands-on QA activities, write and execute tests, and ensure V&V evidence supports FDA 510(k) submissions and commercial software releases.

You will collaborate with regulatory teams, manage defects, and contribute to risk analyses while driving testing priorities in Jira. Experience with medical-device validation is essential.

Qualifications

• Personally write and execute tests for embedded medical-device software.
• Medical-device software V&V in a regulated development environment.
• Document test results and link evidence to requirements.
• Contribute to risk-management activities and risk-based testing.

Responsibilities

• Write and execute test cases against embedded medical-device software.
• Produce verification and validation evidence.
• Report and manage defects through to resolution.
• Contribute to risk analysis, FMEAs and impact analyses.
• Lead testing activities while remaining hands-on.
• Manage testing priorities using Jira sprint boards.

Skills

Test design & execution

V&V in regulated env

Test documentation

Risk-based testing

Hands-on leadership

Tools

Jira

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.

Contract details

• 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.
• Manage testing priorities using Jira sprint boards.
• Support regulatory submission and commercial release deadlines.

Essential experience

• 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.