Hybrid Staff Software Test Engineer, Medical Devices

Posted 3 days ago

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About the role

  • 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

Job title

Staff Software Test Engineer, Medical Devices

Job type

Experience level

Lead

Salary

$139,000 - $228,000 per year

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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