Software Test Engineer ensuring software verification and validation meet FDA standards at SandboxAQ. Leading testing efforts for novel cardiac diagnostic devices in a dynamic startup environment.
Responsibilities
Own the end-to-end software testing lifecycle, including authoring and maintaining comprehensive software test plans, protocols, and reports with full traceability to requirements at the FDA “enhanced software documentation” level.
Drive hands-on verification and validation by designing, writing, and executing tests across multiple layers, including C/C++ firmware, Python backend services, React-based applications, and automated system-level testing.
Design and execute manual system-level and integration testing, particularly for real-world hardware–software interaction scenarios.
Partner with Engineering and Quality to ensure software requirements are clear, testable, and aligned with regulatory expectations.
Contribute to quality system documentation, including risk management artifacts (e.g., software FMEA), traceability matrices, and tool qualification in alignment with SandboxAQ’s Quality Management System (QMS).
Requirements
Bachelor’s degree in Computer Science, Electrical Engineering, or a related technical field
7+ years of experience in software quality, software testing, or V&V roles, with significant experience in regulated medical device development
Strong programming proficiency with hands-on experience writing unit tests in C/C++ and Python
Demonstrated experience authoring and executing software V&V documentation for an FDA 510(k) submission, including both SiMD and SaMD
Deep knowledge of medical device software development lifecycles and standards, particularly IEC 62304
Benefits
Comprehensive medical, dental, and vision coverage for employees and dependents with generous employer premium contributions
Retirement savings with company matching
Paid parental leave
Inclusive family-building benefits
Flexible paid time off
Company-wide seasonal breaks
Support for flexible work arrangements that enable sustainable performance
Opportunities for continuous learning and growth through on-the-job development, cross-functional collaboration, and access to internal learning and development programs
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