Omni Inclusive
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 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 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).
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 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 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).