Principal Embedded V&V Engineer

Job Title: Principal Embedded V&V Engineer

Job Location: Waltham, MA

Job Type: Contract

Pay Range: $55.00hr - $60.00hr

Job Overview:

Experience: 10+ years of commercial software test engineering experience, with a proven track record in a medical device or scientific instrument environment. Deep Embedded Expertise: Extensive, hands-on experience testing deeply embedded systems where software directly controls physical hardware components. Regulatory Mastery: Proven commercial experience testing and shipping medical devices under ISO 13485, along with familiarity with current FDA cybersecurity requirements. Testing Methodologies: Deep familiarity with feature, regression, and integration testing for complex systems. Tooling: Hands-on experience utilizing enterprise Application Lifecycle Management (ALM) systems (such as Azure DevOps) for backlog, sprint board, and test case management.

Nice to Have:

• 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 in developing automated test scripts for hardware-in-the-loop (HIL) environments.

Job Responsibilities:

• Embedded V&V Leadership: Lead the development, review, and execution of software quality assurance processes specifically for embedded medical devices.
• Hardware/Software Integration Testing: Execute manual and automated test cases to verify software that controls hardware as part of an overall scientific instrument system.
• Regulatory Validation: Conduct and oversee software validation activities in strict accordance with FDA regulations and ISO 13485.
• Iterative Process Improvement: Implement tool and process improvements to bring verification test case writing and approval concurrent with iterative Agile development cycles.
• Documentation & Approvals: Review, author, and approve critical software documentation, including validation plans, protocols, summary reports, and cybersecurity risk mitigations.
• Cross-Functional Mentorship: Actively participate in development team ceremonies, review work item acceptance criteria, provide input on estimations, and mentor junior testing staff.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities