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Niche regulated medical-device V&V and Python automation reduces applicant pool despite general QA title.
Medical-device V&V and regulatory validation specialization limits cross-industry transferability.
Mandatory Python automation, regulated medical-device V&V expertise, and traceability/tool experience increases filter strictness.
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Develop and execute system-level Verification & Validation strategies and plans for medical device software and integrated systems.
Design and perform various testing types including integration, functional, regression, performance, reliability, and automation testing using Python.
Collaborate across cross-functional teams to ensure regulatory compliance, risk-based testing, defect analysis, and maintain traceability and documentation throughout the product lifecycle.
Strong experience in system verification and software validation for regulated medical devices.
Mandatory proficiency in Python programming for automation frameworks.
Experience with system integration, functional, regression, performance, and automation testing.
Work Experience Required: Not explicitly mentioned in the JD.
Has a strong background in regulated medical device software V&V with hands-on automation experience using Python.
Experience working collaboratively with cross-disciplinary teams (Software, Hardware, Firmware, Clinical, Regulatory) in complex product lifecycles.
Proficient with test management tools (JIRA, TestRail, Jama), version control (Git), and CI/CD pipelines (Jenkins, Azure DevOps).