ATE Software Validation Engineer Medical Devices Remote Location
Posted 4 days ago by 1755843208
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 such as infusion pumps and patient monitors. This role involves developing validation protocols and collaborating with cross-functional teams to ensure compliance with regulatory standards. The engineer will also support design transfer activities and contribute to continuous improvement in testing methodologies. The position is remote and classified as outside IR35.
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:
- Experience in software validation for medical devices.
- Knowledge of FDA regulations (21 CFR Part 820, Part 11) and ISO 13485.
- Strong collaboration skills with cross-functional teams.
- Proficiency in developing validation protocols and test plans.
- Experience with IQOQPQ processes.
- Ability to interface with hardware and firmware teams.
- Problem-solving skills for software or system-level issues.
- Strong documentation skills in design control and software lifecycle processes.
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.