Software Test Lead - Medical Device Verification & Validation IRC274691
Our client is a global leader in eye care, dedicated to improving lives by enhancing sight. With a diverse portfolio of innovative products-including contact lenses, eye care solutions, and surgical instruments for cataract and retina procedures-they serve customers in more than 140 countries. By advancing technologies and solutions, they continue to shape the future of eye health worldwide. About the Project:
Our client is now enhancing their medical devices with advanced connectivity features and cloud-based services. Because next-generation adoption in the field is gradual, the project must ensure smooth integration of both legacy and modern systems within the same environment. The mission is to design and deliver a comprehensive set of tools, services, and libraries that allow seamless interoperability of existing devices with cloud and on-premises infrastructures-ensuring data integrity, security, and reliability across all systems. Requirements
- 7+ years in software testing, with 3+ years in a lead or managerial role.
- Strong background in regulated domains (medical preferred; automotive, aerospace also valuable).
- Hands-on experience with test management tools (e.g., Polarion, Azure DevOps).
- Experience in automation scripting, ideally with Python or similar.
- Strong understanding of software development lifecycle models (Agile, V-model, etc.).
- Excellent communication, leadership, and problem-solving skills.
- English fluency required
- ISTQB Advanced certification or equivalent.
- Familiarity with cybersecurity testing, safety-critical systems, or surgical software.
- Knowledge of risk-based testing and traceability frameworks in medical environments.
- Define and execute a comprehensive V&V strategy across unit, integration, system, and acceptance levels.
- Align testing with system requirements, risk analysis, and quality standards.
- Oversee creation and maintenance of test plans, test protocols, and traceable documentation.
- Lead and mentor a cross-functional team of testers and V&V engineers.
- Select and implement appropriate automation tools and frameworks (e.g., Python, Ranorex).
- Facilitate defect triage, manage issue resolution, and support test execution.
- Ensure audit readiness and support regulatory submissions alongside quality and RA teams.
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