Katalyst Healthcares and Life Sciences
ATE Software Validation Engineer
Katalyst Healthcares and Life Sciences, Skaneateles, New York, United States, 13152
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. utomatic Test Equipment (ATE) Software Validation Engineer. 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.
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. utomatic Test Equipment (ATE) Software Validation Engineer. 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.