ATE Software Validation Engineer - Medical Devices Skaneateles Falls - NY - New York

Overview

On Site
$45 - $45
Accepts corp to corp applications
Contract - W2
Contract - 12 month(s)

Skills

Automatic Test Equipment (ATE) Software Validation Engineer
FDA Regulations
ISO 13485

Job Details

Skaneateles Falls NY

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 IQOQPQ 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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