Automation Test Lead

Automation Test Lead – System and Software Testing for Medical Device (Electrosurgical)

Location: Austin, TX

• 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 ISTQBAdvanced 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., Vector Cast/Ldra) as needed to automate testing of C/C++-based firmware and software, ensuring compliance with medical device standards.
• Leverage CStat/CRun, Sonar Qube 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 Lab View testing protocols.
  • Extensive 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 Sonar Qube, 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, Git Lab CI, or similar) for integrating tests into Dev Ops 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).