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.
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Lead QA Engineer – Medical Device Embedded Software Testing in Motherwell employer: Hydrogen UK Ltd
Hydrogen UK Ltd is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the public sector and defence landscape. Employees benefit from comprehensive professional development opportunities, competitive remuneration, and the chance to engage with cutting-edge technologies while making a meaningful impact on government programmes. Located in a vibrant area, the company promotes a supportive environment where every team member's contributions are valued and recognised.
