Principal Embedded V&V Engineer

Cynet Systems • Waltham, MA

1d

About The Position

The Principal Embedded V&V Engineer leads software quality assurance for embedded medical devices and scientific instruments. The role involves verifying software that directly controls physical hardware, executing manual and automated tests, and ensuring software validation complies with FDA regulations and ISO 13485. The engineer improves verification processes so test case writing and approval keep pace with iterative Agile development, reviews and approves critical software documentation, and contributes to development team ceremonies while mentoring junior testing staff.

Requirements

• 10 or more years of commercial software test engineering experience.
• Proven track record in a medical device or scientific instrument environment.
• Extensive hands-on experience testing deeply embedded systems where software directly controls physical hardware components.
• Commercial experience testing and shipping medical devices under ISO 13485.
• Familiarity with current FDA cybersecurity requirements.
• Deep familiarity with feature, regression, and integration testing for complex systems.
• Hands-on experience using enterprise Application Lifecycle Management (ALM) systems, such as Azure DevOps, for backlog, sprint board, and test case management.

Nice To Haves

• Previous experience acting as a V&V Manager or Test Lead.
• Bachelor's degree or higher in computer science, engineering, or a related technical discipline.
• Background developing automated test scripts for hardware-in-the-loop (HIL) environments.

Responsibilities

• Lead development, review, and execution of software quality assurance processes for embedded medical devices.
• Execute manual and automated test cases to verify software that controls hardware within scientific instrument systems.
• Conduct and oversee software validation activities in accordance with FDA regulations and ISO 13485.
• Implement tool and process improvements to align verification test case writing and approval with iterative Agile development cycles.
• Review, author, and approve software validation plans, protocols, summary reports, and cybersecurity risk mitigations.
• Participate in development team ceremonies, review work item acceptance criteria, and provide input on estimations.
• Mentor junior testing staff.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed