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The Test Team Lead is accountable for the planning, coordination, and execution of software and hardware verification and validation activities for regulated medical device systems, ensuring that software and hardware meet defined safety, quality, performance, and regulatory requirements throughout the product lifecycle. This role is responsible for leading a team of testers, establishing and maintaining robust test practices and documentation, and ensuring full traceability between requirements, risks, and test outcomes using tools such as Jira and Jama in alignment with applicable medical device standards and regulations. The role also supports hardware test protocol development, hands-on hardware testing, and coordination of internal and external hardware testing activities, including collaboration with third-party laboratories and cross-functional engineering teams.
Job Responsibility:
Lead, mentor, and supervise a team of software testers, providing direction, coaching, and performance feedback to ensure effective delivery of testing activities
Develop, maintain, and execute V&V plans, test strategies, protocols, and reports in accordance with internal procedures and relevant medical device standards and regulations
Define, document, and manage acceptance criteria and test cases in Jira and Jama, ensuring complete bidirectional traceability between requirements, risk controls, and executed tests
Develop and execute test protocols to verify system performance and compliance
Coordinate with external testing laboratories to manage testing schedules, documentation, and reporting
Perform hands-on hardware testing and develop test protocols using laboratory equipment and measurement tools
Design and oversee the execution of manual and automated test suites, including functional, regression, integration, and system-level tests for medical device software
Collaborate with clinical stakeholders to design and execute clinically relevant test scenarios that reflect real-world workflows, user needs, and patient safety considerations
Ensure effective defect management, including logging, triage, prioritization, root cause analysis support, and verification of corrective actions
Coordinate with software development, systems engineering, quality, clinical and regulatory teams to align test coverage with design inputs, risk assessments, and project schedules
Prepare and maintain clear, accurate, and audit-ready test documentation to support design reviews, internal audits, and regulatory submissions
Requirements:
Bachelor’s degree in computer science, Software Engineering, Biomedical Engineering, or related field
Minimum of five (5) years of experience in software and/or system testing within the medical device or similarly regulated industry, including experience in a senior or lead role
Demonstrated knowledge of medical device regulations and software lifecycle standards, including IEC 62304, ISO 13485, ISO 14971 and IEC 60601
Strong hands-on experience with Jira and Jama (or equivalent ALM tools) for requirements management, test case management, defect tracking, and maintaining bidirectional traceability
Practical experience with automated testing, including defining what to automate, working with automation frameworks, and integrating tests into CI/CD pipelines
Proven ability to collaborate with clinical users or subject matter experts to translate clinical workflows and risks into meaningful, clinically relevant test scenarios
Demonstrated leadership skills, including team coordination, mentoring, workload planning, and promoting a culture of quality and continuous improvement
Excellent written and verbal communication skills, with a strong focus on clear, structured, and compliant documentation
Nice to have:
Experience with biocompatibility, sterilization, cleaning validation, and packaging testing