Schedule: Monday–Friday, 8:00 AM–4:30 PM (flexible start time between 7:00–9:00 AM)
Job Summary
We are seeking a hands‑on Test Engineer to support a production capacity expansion project for a Class III medical device product line. This individual will play a key role in procuring, assembling, troubleshooting, and validating additional automated test stations used in production.
The primary focus of this position is equipment validation, including Installation Qualification (IQ) and Performance Qualification (PQ), to ensure new test stations meet established engineering and quality requirements before being released for production use.
The ideal candidate is self-driven, detail-oriented, and comfortable collaborating with cross‑functional engineering and technical teams in a regulated manufacturing environment.
Key Responsibilities
- Support production capacity expansion through the setup and implementation of additional automated test stations.
- Coordinate equipment procurement, assembly, and installation activities.
- Execute equipment validation activities, including Installation Qualification (IQ) and Performance Qualification (PQ).
- Develop and execute validation plans, protocols, and reports.
- Perform replicate validations to demonstrate equipment consistency and reliability.
- Support characterization testing, troubleshooting, and resolution of equipment or testing issues.
- Ensure test equipment is properly validated and qualified before release for production use.
- Collaborate with test engineers, technicians, and cross‑functional stakeholders to support project deliverables.
- Monitor project progress, communicate status updates, and identify potential risks or delays.
- Ensure all engineering activities comply with established quality procedures and applicable medical device standards.
Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Previous experience in equipment validation, test engineering, manufacturing engineering, or a related field.
- Knowledge or hands‑on experience with IQ/PQ validation activities.
- Experience developing or executing validation protocols, plans, and reports is highly preferred.
- Familiarity with automated test equipment, production testing, or troubleshooting is a plus.
- Experience in a regulated manufacturing environment, preferably medical devices.
- Strong organizational, communication, and problem‑solving skills.
- Ability to work independently while collaborating effectively with cross‑functional teams.
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