Software Validation Engineer ATE Systems (Medical Devices)

Software Validation Engineer ATE Systems (Medical Devices)
Location: New York, USA

Are you passionate about ensuring the safety and reliability of life-saving medical devices? We re looking for a Software Validation Engineer to lead validation efforts for Automated Test Equipment (ATE) systems used in testing infusion pumps, patient monitors, and diagnostic devices.

Key Responsibilities
Lead software validation for ATE systems aligned with FDA 21 CFR Part 820, Part 11, ISO 13485.
Develop validation protocols, test plans, test scripts, and reports.
Perform IQ/OQ/PQ for ATE systems ensuring full requirements traceability.
Collaborate with R&D, Quality, and Manufacturing teams to ensure compliance and efficiency.
Troubleshoot and resolve software/system-level issues during validation or production.
Drive continuous improvement in test methodologies and automation.

Qualifications
Bachelor s or Master s in Electrical/Computer/Biomedical Engineering or related field.
Strong experience in ATE software validation (medical devices preferred).
Knowledge of FDA regulations, ISO 13485, IEC 62304, ISO 14971.
Hands-on with LabVIEW, TestStand, Python, C/C++.
Familiar with test equipment (oscilloscopes, signal generators, analyzers).
Excellent problem-solving, documentation, and communication skills.

Preferred
Experience validating ATE for infusion systems, respiratory care, or hospital beds.
If you re ready to make a real impact in healthcare technology, we d love to connect!