ATE Software Validation Engineer
Katalyst HealthCares & Life Sciences
- Skaneateles, NY
- Permanent
- Full-time
- 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.