Validation Engineer - Medical Devices (LabVIEW, IQ/OQ/PQ)

Creative Solutions Services, LLC; Boxborough (MA); On-site; USD 80,000 - 105,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Test Engineer to qualify automated functional testers and execute the corresponding validations in a regulated medical-device environment.

The role involves writing comprehensive documentation, including requirements, trace matrices, protocols and reports, and collaborating with internal teams to ensure systems meet IQ/OQ/PQ standards. Hardware assembly support may be required.

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• Experience in verification/validation testing in medical devices or regulated industries.
• Familiarity with automated test systems and documentation best practices.
• Strong analytical, documentation, and problem solving skills.
• Experience as tester development for manufacturing environments.
• Experience with validations within MFG environments - IQ/OQ/PQ.
• Bonus: background in Test Stand LabVIEW to aid debugging and tracing requirements.

Responsibilities

• Test Stand & LabVIEW experience with manufacturing equipment validations (IQ/OQ/PQ).
• Qualify automated functional testers and support troubleshooting.
• Write all documentation (requirements, trace matrices, protocols, reports) using healthcare templates.
• Collaborate with internal resources to complete paperwork and qualify systems.
• Assist in assembling hardware side of testers as needed.
• Develop and maintain validation documentation and test protocols.

Skills

Functional Testing

Documentation

Problem solving

Analytical

Education

Bachelor's degree in Engineering

Tools

Test Stand

LabVIEW

IQ/OQ/PQ

Job description

Creative Solutions Services, LLC is seeking a Test Engineer to qualify automated functional testers and execute the corresponding validations in a regulated medical-device environment.

The role involves writing comprehensive documentation, including requirements, trace matrices, protocols and reports, and collaborating with internal teams to ensure systems meet IQ/OQ/PQ standards. Hardware assembly support may be required.