Overview
Skills
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.
Requirements:
>> Bachelors or Masters degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field.
>> Experience in ATE software validation, preferably in the medical device industry.
>> Strong knowledge of FDA regulations, ISO 13485, and IEC 62304 for software lifecycle processes.
>> Hands-on experience with LabVIEW, TestStand, or similar ATE development environments.
>> Experience working in a regulated environment with formal document control and change control processes.
>> Strong analytical, documentation, and communication skills.