Roles & 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.

• 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