Hydrogen Group
Lead QA Engineer - Medical Device Embedded Software Testing
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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
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Applications are welcome from local candidates and those based further away who can travel to Motherwell:
- 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.
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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.
To apply, send your CV, availability, location and day-rate expectations. Please name the medical device(s) you've worked on and briefly describe the embedded software testing you personally performed.
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