Our client, a leading medical device company, has engaged GForce Life Sciences to provide a Test Engineer to support production capacity expansion for the LP35 product line. This role will focus on assembling automated test stations, completing equipment validations (IQ/PQ), and documenting validation plans and reports to ensure test equipment meets manufacturing and quality requirements. The ideal candidate has a background in test engineering or equipment validation, basic hardware troubleshooting skills, and strong communication skills.
Responsibilities
- Support a production capacity expansion project by procuring, assembling, and replicating automated test stations.
- Develop and execute equipment validation plans, including Installation Qualification (IQ) and Performance Qualification (PQ).
- Perform replicate validations to confirm additional test stations operate consistently with established equipment and testing requirements.
- Write validation protocols and plans, execute test activities, document results, and prepare formal validation reports.
- Support manufacturing test operations to ensure products meet functional requirements before release to customers.
- Perform basic hardware troubleshooting and assist with resolving test equipment issues as needed.
- Collaborate with test engineers, test technicians, Quality, and Regulatory teams to support validation and production readiness.
- Communicate project status, progress, and potential risks to relevant stakeholders.
- Ensure all engineering activities comply with established procedures, quality standards, and applicable regulatory requirements.
Qualifications
- Bachelor's degree in Engineering or a related field, or equivalent practical experience.
- Experience in test engineering, test equipment, hardware testing, or a related engineering environment.
- Validation experience, particularly IQ/PQ, is highly preferred.
- Experience developing validation plans, executing test protocols, and preparing validation reports is a plus.
- Basic hardware troubleshooting skills and the ability to investigate and resolve equipment issues.
- Strong written and verbal communication skills.
- Self-motivated with the ability to work independently and manage assigned tasks with minimal supervision.
- Ability to collaborate effectively with cross-functional teams, including Engineering, Quality, Regulatory, and Test Technicians.
- Medical device or other regulated manufacturing experience is beneficial.
