Job Description

Position: Test Systems Validation Engineer
Location: Skaneateles Falls, NY (Day 1 Onsite)

Experience: 5 - 7 years

We are seeking an Test Systems Validation Engineer to lead validation efforts for automated test equipment (ATE) used in testing medical devices such as infusion pumps, patient monitors, and diagnostic systems. The role requires strong technical expertise, knowledge of regulatory standards, and collaboration with cross-functional teams to ensure compliance and product quality.

• Lead software validation activities for ATE systems supporting medical device testing.

• Develop and execute validation protocols, test plans, scripts, and reports in compliance with FDA 21 CFR Part 820/11 and ISO 13485.

• Perform IQ/OQ/PQ for ATE systems and ensure full requirements traceability to test execution.

• Collaborate with R&D, Quality, and Manufacturing teams to define validation requirements and risk-based testing strategies.

• Partner with hardware and firmware engineers to ensure smooth ATE integration and robust test coverage.

• Support design transfer from R&D to manufacturing, ensuring ATE systems meet production needs.

• Troubleshoot and resolve software or system-level issues identified during validation or production.

• Drive continuous improvement of validation methodologies, automation frameworks, and best practices.

• Maintain accurate documentation in compliance with design control and software lifecycle requirements.

• Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related discipline.

• Proven experience in ATE software validation, ideally within the medical device industry.

• Strong understanding of FDA regulations, ISO 13485, and IEC 62304 for software lifecycle processes.

• Hands-on expertise with:

  • LabVIEW, TestStand, or similar ATE development platforms.

  • Python, C/C++, or other scripting languages for test automation.

  • Test instruments such as oscilloscopes, signal generators, multimeters, and communication analyzers.

• Familiarity with risk management (ISO 14971) and requirements traceability tools (e.g., DOORS, Jama).

• Experience working in regulated environments with formal document and change control processes.

• Excellent problem-solving, documentation, and communication skills.

• Direct experience validating ATE systems for infusion devices, respiratory care equipment, or hospital beds.

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