Senior Software Test Engineer

About the Role

Key Responsibilities

• Evaluate software using automated or manual testing methods and analyze the results.
• Create testing procedures to evaluate the performance of the software.
• Build software testing programs that automate testing processes for Desktop applications running in Windows.
• Run the software testing procedures to evaluate the software.
• Document all testing procedures according to department standards and SOPs.
• Report bugs and make recommendations to improve the software product.
• Retest software after bugs are fixed to ensure proper functionality.
• Attend meetings with the development team, stakeholders, and other groups.
• Perform software testing against the requirements on the medical device and emulator.
• Perform software unit testing for software test tools.
• Perform code analysis, profiling, and debugging on software tools used for testing of the Desktop Application hosted on medical devices.
• Perform code reviews on Desktop Applications hosted on medical devices.
• Provide input to the software requirements for the host application and software tools.
• Architect and implement software test automation tools for Desktop Applications hosted on medical devices.
• Document test protocols, test results, and perform full requirements traceability according to FDA 510K documentation requirements.
• Write software requirements and specification documents for in-house test tools.
• Make observations, take measurements using laboratory equipment, process data, perform statistical analysis, and carry out test protocols.
• Test, debug, and troubleshoot system software (e.g., Visual Studio).
• Work with software development to identify root causes of issues, and prepare test cases, plans, and procedures.
• Participate in design reviews of test tools, forms processing for software releases, and documentation.
• Support a schedule-oriented work ethic and approach to technical issues.
• This position requires on-site presence.

Requirements

• Bachelor of Science in Computer Science, Physics, Math, or Electrical Engineering.
• 10+ years experience in software testing.
• Experience creating and deploying software test automation for Embedded Windows Applications.
• Ability to adapt to changing priorities.
• Proficient with automation tools (e.g., Qt Squish, Selenium, Appium, or equivalent) used for testing applications on Windows Embedded medical devices.
• Experience with Windows Operating System.
• Proficient with Atlassian Jira and BitBucket.
• Skilled in developing software test protocol documentation and capturing test results for medical devices.
• Proficient in programming languages such as Python, Bash, Java, or equivalent for writing tests.
• Ability to perform code reviews in C/C++.
• Experience testing software hosted on medical devices and familiarity with standards like IEC62304.
• Experience designing and running unit tests.
• Knowledge of FDA cybersecurity requirements, NIST, GDPR, EU ENISA (preferred).
• Knowledge of B-Mode Ultrasound and real-time systems (preferred).

Nice to Have

• Knowledge on B-Mode Ultrasound.
• Design experience with real-time systems, state machines, and standard Windows applications.
• Knowledge of FDA cybersecurity requirements, NIST, GDPR, EU ENISA.
• Software testing experience for FDA medical devices.

Qualifications

• Bachelor of Science degree in relevant field.
• 10+ years of experience in software testing.