Develop and maintain comprehensive V&V plans, including Verification Plans, Validation Plans, Test Protocols, Test Reports, and Traceability Matrices
Define system-level test strategies for software, hardware, and integrated platforms in compliance with FDA 21 CFR 820.30, ISO 13485, IEC 62304, etc.
Execute verification and validation test protocols, including functional, regression, performance, and usability testing
Document objective evidence and maintain high-quality engineering records suitable for regulatory audits and submissions
Ensure full traceability between user needs, system/software requirements, risk controls, and test cases
Work closely with Mechanical Engineering and Operations to clarify requirements and ensure they are testable and unambiguous
Partner with Software, Clinical, and Quality teams to identify defects early and improve design robustness
Manage test environments—including configurations for hardware, imaging datasets, and software builds
Conduct integrated testing across imaging, planning software, and hardware subsystems.

Bachelor’s or Master’s degree in Biomedical Engineering, Systems Engineering, Computer Science, Mechanical Engineering, or related field
5+ years of experience in V&V for medical devices or other regulated industries
Strong knowledge of FDA, ISO 13485, IEC 62304, etc. standards and Design Controls
Hands-on experience writing V&V documentation (test plans, protocols, reports, trace matrices)
Proficiency in testing complex systems that combine software, hardware, and clinical workflows
Familiarity with defect tracking and test management tools (e.g., Jira, TestRail, Jama)
Strong analytical, troubleshooting, and communication skills
Experience with imaging-based systems, surgical workflows, or cloud-connected devices is a plus
Background supporting regulatory submissions such as 510(k) is preferred.

Senior Verification & Validation Engineer

Key skills