ATE Software Validation Engineer – Medical Devices

Key Responsibilities:Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or -diagnostic devices.Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485.Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define software validation requirements and risk-based testing strategies.Perform IQ/OQ/PQ for ATE systems and ensure traceability from requirements to test execution.Interface with hardware and firmware teams to ensure seamless ATE integration and accurate test coverage.Support design transfer activities from R&D to manufacturing and ensure test systems meet production needs.Investigate and resolve software or system-level issues found during validation or manufacturing use.Contribute to continuous improvement of test methodologies, automation tools, and validation best practices.Maintain accurate documentation per design control and software lifecycle processes.Regards,Mohammed ilyas,PH - 229-264-4024 or Text - 229-469-1455 or You can share the updated resume at Mohammed@vtekis. com