Staff Software Test Engineer (Medical Devices)

TL;DR

Staff Software Test Engineer (Medical Devices): Driving software verification and validation for a novel medical device, ensuring compliance with FDA regulatory requirements and supporting rapid product development. Focus on end-to-end software testing, hands-on V&V across firmware, backend, and React applications, and producing submission-ready documentation.

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

Compensation: $139,000–$228,000

Company

hirify.global is a high-growth company delivering AI solutions that address global challenges, focusing on Large Quantitative Models in life sciences, financial services, navigation, and cybersecurity.

What you will do

• Own the software testing lifecycle, including authoring and maintaining comprehensive software test plans, protocols, and reports with traceability to FDA requirements.
• Drive hands-on verification and validation by designing, writing, and executing tests across C/C++ firmware, Python backend, and React applications.
• Design and execute manual system-level and integration testing for real-world hardware–software interaction scenarios.
• Partner with Engineering and Quality to ensure software requirements are clear, testable, and regulatory-aligned.
• Contribute to quality system documentation, including risk management artifacts and traceability matrices, in alignment with the 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.

Nice to have

• Experience testing complex systems spanning firmware, application software, and cloud services.
• Hands-on experience with modern test automation tools and frameworks (e.g., Playwright, pytest, Storybook).
• Experience working with CI/CD pipelines, particularly GitHub Actions.
• Familiarity with device fleet management and configuration tools such as Ansible or Mender.
• Prior experience supporting diagnostic or cardiology medical devices.

Culture & Benefits

• Competitive base salary, performance-based incentives or bonuses, and equity participation.
• Comprehensive medical, dental, and vision coverage for employees and dependents with generous employer contributions.
• Retirement savings with company matching, paid parental leave, and inclusive family-building benefits.
• Flexible paid time off, company-wide seasonal breaks, and support for flexible work arrangements.
• Opportunities for continuous learning and growth through on-the-job development and cross-functional collaboration.