ATE Software Validation Engineer
ATE Software Validation Engineer
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1 Vacancy
Job Description
- 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.
- Automatic Test Equipment (ATE) Software Validation Engineer.
- 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.
Employment Type
Full-time
