Lead QA Engineer - Embedded Medical Device Testing & V&V

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

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.