ATE Software Validation Engineer – Amazon Store

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Position- ATE Software Validation Engineer Medical Devices

Location : 4619 Jordan Rd, Skaneateles Falls, NY 13153 ( Day 1 onsite)

JD:

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.

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