Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Skills
ATE
Automatic Test Equipment
Validation
Medical Devices
Job Details
Job Title: ATE Software Validation Engineer Medical Devices
Location: Skaneateles Falls, NY (Onsite)
Duration : Long-Term
Interview Mode : Video
Job Description :
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.
Key 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.
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