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Urgent! ATE Software Validation Engineer Job Opening In Skaneateles New York – Now Hiring Katalyst Healthcares & Life Sciences

ATE Software Validation Engineer



Job description

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.





Required Skill Profession

Other General



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