ATE Software Validation Engineer - Medical Devices Remote Location
Posted Today by 1758179046
Negotiable
Outside
Remote
USA
Summary: The ATE Software Validation Engineer will lead software validation efforts for automated test equipment (ATE) systems used in medical devices, ensuring compliance with FDA and ISO standards. The role involves developing validation protocols, collaborating with cross-functional teams, and maintaining documentation throughout the software lifecycle. The engineer will also support design transfer activities and contribute to continuous improvement initiatives. This position requires a strong background in software validation within the medical device industry.
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 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
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.