Software Validation Engineer

Position: Software Validation Engineer Location: Skaneateles Falls, NY (Onsite) Experience: 5 - 8 Years Employment Type: Contract

Job Description

We are seeking an Automatic Test Equipment (ATE) Software Validation Engineer to lead validation activities for systems used in testing infusion pumps, patient monitors, and diagnostic devices. This role requires strong knowledge of FDA regulations and medical device standards, along with hands-on experience in developing and executing validation protocols for complex test systems.

Key Responsibilities

Lead software validation efforts for ATE systems supporting medical devices.

Develop validation protocols, test plans, scripts, and reports compliant with FDA 21 CFR Part 820, Part 11, and ISO 13485 .

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

Execute and document IQ/OQ/PQ activities for ATE systems, ensuring complete traceability from requirements through test execution.

Partner with hardware and firmware teams to ensure accurate ATE integration and test coverage.

Support design transfer from R&D to manufacturing, ensuring test systems are production-ready.

Troubleshoot and resolve software or system-level issues discovered during validation or production use.

Drive continuous improvement of test methodologies, automation tools, and validation practices.

Maintain compliant documentation in alignment with design control and software lifecycle processes.

Required Skills & Qualifications

Proven experience in ATE software validation within medical device or regulated industries.

Strong understanding of FDA 21 CFR Part 820, Part 11, ISO 13485 .

Hands-on expertise in developing and executing validation protocols and test plans.

Experience with IQ/OQ/PQ processes.

Ability to collaborate across R&D, Quality, and Manufacturing teams.

Strong troubleshooting and problem-solving skills.

Excellent documentation and communication skills.