ATE Software Validation Engineer – Medical Devices

About the position

We provide Recruitment and Staffing services to many industries and domain through our innovative and customized solutions and passionate commitment to research. Ability to understand the hiring strategies, availability of talent and compensation benchmarking makes us proud hiring partner for various industries. We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

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.