Test/Validation Engineer (1688-1)
About The Position
The Test/Validation Engineer will support a manufacturing and production expansion project for a medical device organization in Redmond, Washington. The role primarily focuses on validating automated test stations and equipment used in manufacturing, ensuring newly assembled equipment is properly validated, documented, and ready for production use in an environment supporting Class III medical devices. The engineer will support the expansion and implementation of automated test stations, develop and execute validation plans and protocols, participate in IQ/OQ/PQ activities, perform characterization testing and troubleshooting, and maintain technical documentation. The role involves close collaboration with engineering, technician, manufacturing, and other cross-functional teams, as well as communicating project risks, issues, and status to stakeholders.
Requirements
- Bachelor’s degree in Engineering or a related technical field, or equivalent practical experience.
- Experience in test engineering, manufacturing engineering, equipment engineering, or a closely related field.
- Strong written and verbal communication skills.
- Ability to work collaboratively with engineers, technicians, and cross-functional teams.
Nice To Haves
- Experience with equipment or process validation in a manufacturing environment.
- Hands-on experience with IQ/OQ/PQ or similar validation methodologies.
- Experience writing and executing validation plans, protocols, and reports.
- Troubleshooting experience with automated test equipment or test stations.
- Experience in a medical device, pharmaceutical, or other regulated manufacturing environment.
Responsibilities
- Support the expansion and implementation of automated test stations for production and troubleshooting activities.
- Validate newly assembled test equipment before it is released for production use.
- Develop and execute validation plans, protocols, and reports.
- Support IQ/OQ/PQ (Installation, Operational, and Performance Qualification) activities and replicate validation testing.
- Perform characterization testing, troubleshooting, and verification of test equipment.
- Review and maintain technical documentation associated with test station validation.
- Collaborate with test engineers, technicians, manufacturing teams, and other cross-functional stakeholders.
- Identify and communicate project risks, issues, and status to key stakeholders.
