Staff Software Test Engineer, Medical Devices

SandboxAQ • Palo Alto, CA

33d • Hybrid

About The Position

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 filing. In 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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 FDA’s “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 SandboxAQ’s Quality Management System (QMS)

Benefits

• We offer competitive salaries, stock options depending on employment type, generous learning opportunities, medical/dental/vision, family planning/fertility, PTO (summer and winter breaks), financial wellness resources, 401(k) plans, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees