Test Lead - Manual

Test Lead - Manual

Understand, develop, and execute verification test methods, protocols, and reports in accordance with product requirements and regulatory standards (IEC 62304, ISO 13485, ISO 14971, FDA).

• Analyze system requirements and design comprehensive test cases.
• Ensure full requirements traceability and test coverage throughout the product lifecycle.
• Review and approve test protocols, test reports, and verification documentation.
• Collaborate with cross-functional teams including Systems Engineering, R&D, Quality Assurance, Regulatory Affairs, and Product Management.
• Identify, document, track, and resolve defects using defect management tools.
• Lead test planning, execution, effort estimation, risk assessment, and status reporting.
• Ensure compliance with medical device quality standards and industry best practices.
• Experience working with Application Lifecycle Management (ALM) and defect tracking tools such as:
• JAMA
• JIRA
• Similar requirements and test management tools

Bachelor's