Staff Software Test Engineer, Medical Devices

About the Role

AQMed is developing a next-generation non-invasive cardiac diagnostic device to revolutionize heart health. We are seeking a highly experienced Software Quality Test Engineer to drive our software verification and validation efforts.

Your mission: to take complete ownership of the software testing lifecycle for our novel medical device. You will be responsible for directly creating comprehensive test plans executing a majority of the testing work and generating submission-ready reports essential for our FDA 510(k) regulatory this role you will be a cornerstone of our software quality efforts working closely with software engineers quality specialists and regulatory affairs to ensure our device meets the highest standards of safety efficacy and documentation excellence for regulatory scrutiny. A key challenge in this role will be to pragmatically balance the rigor required for FDA compliance with the speed and agility of a startup environment. While your core focus will be on SW testing / V&V this role offers the opportunity to contribute to the broader software quality system.

What Youll Do

• Develop write and own clear and comprehensive software test plans protocols and procedures for a complex medical device system ensuring full traceability to software requirements at FDAs enhanced SW documentation level.
• Drive the hands-on V&V effort by writing and integrating tests at multiple levels: unit tests directly into the C/C firmware and Python backend codebases component tests for our React applications and automated system-level tests.
• Design and execute comprehensive manual system-level and integration test protocols particularly for scenarios involving real-world hardware interactions.
• Provide input into the requirements definition process to ensure all software requirements are clear concise and verifiable.
• Collaborate on a range of quality system documents such as risk management files (e.g. swFMEA) and traceability matrices to support the overall submission.
• Ensure all software testing activities and documentation comply with medical device standards (e.g. IEC 62304) and our internal Quality Management System (QMS).
• Proactively provide product quality feedback to Engineering and help drive root cause/fix to improve user satisfaction and user experience
• Voice of Quality for the Software team to influence software development to be compliant with applicable software development standards for medical devices.
• Own identification qualification and maintenance of relevant software development and V&V tools per SandboxAQs Quality Management System (QMS)

Required Qualifications

• B.S. in Computer Science Electrical Engineering or a related technical field.
• 7 years of experience in a software quality or testing role with a significant portion spent in the medical device industry.
• Strong programming proficiency with demonstrated experience writing unit tests in both C/C and Python.
• Demonstrated hands-on experience authoring and executing software V&V test plans and reports for a 510(k) medical device submission (both SiMD and SaMD).
• Deep understanding of medical device software development lifecycles and standards particularly IEC 62304.
• Experience testing complex multi-component systems that include firmware software and cloud elements.
• Authorization to work in the United States.

Preferred Qualifications

• Hands-on experience with modern test automation frameworks and tools specifically playwright pytest and storybook.
• Experience with CI/CD pipelines particularly GitHub Actions.
• Familiarity with device fleet management and configuration tools like Ansible and Mender.
• Proficiency with test management and QMS tools.
• Previous experience with diagnostic or cardiology devices.

Key Competencies & Personal Attributes

• A proactive self-starter mentality coupled with a strong sense of ownership accountability and a bias for action.
• Ability to work independently and take full ownership of the SW V&V process.
• A pragmatic and risk-based approach with the ability to find efficient solutions that satisfy regulatory requirements without hindering innovation.
• A passion for clarity and precision in all forms of communication especially in written documentation.
• Comfort with ambiguity and the ability to thrive adapt and maintain high performance in a rapidly evolving environment.
• A meticulous attention to detail combined with a roll-up-your-sleeves attitude to personally drive projects to completion.

Note: The ideal candidate will be based out of our Palo Alto offices and work on-site at least 50% of the time.

The US base salary range for this full-time position is expected to be $154k - $216k per year. Our salary ranges are determined by role and level. Within the range individual pay is determined by factors including job-related skills experience and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.