Hybrid Staff Software Test Engineer, Medical Devices

at SandboxAQ

• Job title: Staff Software Test Engineer, Medical Devices
• Job type: Full Time
• Experience level: Lead
• Salary: $154,000 - $216,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cloud, Python, React
• Location requirements: Hybrid, Palo Alto, United States

About the role

• Software Quality Test Engineer managing software verification and validation for a cardiac diagnostic device. Ensuring compliance with FDA standards in a collaborative, innovative environment.

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)

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.

Benefits

• 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