Automation Test Lead - System and Software Testing for Medical Device (Electrosurgical)
Location : Austin, TX
Preferred Qualifications
- Experience testing medical devices with Electrosurgical or RF-based technologies (e.g., ENT, orthopedics, surgical devices).
- Familiarity with Selenium (for UI testing), TestNG, Postman (API testing), or JMeter (performance testing).
- Hands-on experience with hardware-in-the-loop (HIL) testing or real-time system verification in FreeRTOS or bare-metal environments.
- Deep knowledge of FreeRTOS and bare-metal programming for medical devices.
- Certifications like ISTQB Advanced Level, Certified Medical Device Professional (CMDP), or Agile / Scrum Master.
- Define objectives, scope, and methodologies for unit, integration, software, and system testing, aligning with standards (e.g., IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820).
- Lead the design and maintenance of automation frameworks using Python, Labview or similar (e.g., Perl, Ruby) for system, software, integration, and unit testing in FreeRTOS and bare-metal environments.
- Lead the development of build pipelines using Jenkins or similar
- Develop and utilize automation tools (e.g., VectorCast / Ldra) as needed to automate testing of C / C++-based firmware and software, ensuring compliance with medical device standards.
- Leverage CStat / CRun, SonarQube or similar for static code analysis to maintain code quality, reduce technical debt, and ensure adherence to standards (e.g., MISRA, ISO / IEC).
- 7+ years in test automation, with 2-4 years in a technical leadership role, preferably in medical device development.
Proven expertise in system and software testing for medical devices, ideally with Electrosurgical or RF-based technologies.
Proven experience in developing python or LabView testing protocolsExtensive experience in unit and integration testing for embedded systems and software, particularly in FreeRTOS and bare-metal environments.Strong expertise in Python for automation frameworks and scripts; familiarity with C / C++ for embedded systems testing is required.Proficiency with automation tools (e.g., Ceedling, Unity, CMock, Tessy, or similar) for unit and integration testing, including coverage analysis (e.g., statement, branch, MC / DC).Experience with SonarQube, Coverity, Klocwork, or similar for static code analysis and compliance.Python programming; expertise with PyTest, Robot Framework, or similar for software and system-level testing.Strong knowledge of CI / CD tools (e.g., Jenkins, Git, GitLab CI, or similar) for integrating tests into DevOps pipelines.
Proficiency with Git and test management tools (e.g., JIRA, ALM).Experience with FreeRTOS and bare-metal environments for firmware testing, including real-time constraints and resource-limited systems.Understanding of IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820, and software development lifecycle (SDLC).