Mechanical Engineering Technician
Roles & Responsibilities
- Author test methods, protocols, method validations, and reports with minimal supervision.
- Plan and perform experiments to support new product or technology feasibility testing.
- Conduct testing, applying appropriate test methods, protocols, specifications, and equipment (product and/or equipment testing).
- Adhere to ZebraSci Quality Systems, including the timely identification, notification, and investigation of potential Quality Events (e.g., OOS, Deviations, CAPA).
- Communicate project progress and results effectively within the Technology Development and operations team, both orally and in writing.
- Maintain lab and storage areas in a clean and organized manner.
Experience Required
- 1-5 years of experience in combination product or medical device development and/or testing, with a Bachelor\'s degree.
Skills & Certifications
- Knowledge of drug-device combination products and/or medical devices.
- Experience with mechanical measurement equipment (e.g., Instron, Zwick), vision systems (Keyence), and container closure integrity instrumentation.
- Proficiency in test method development and validation (e.g., MSA, Gage R&R).
- Application of statistical and analytical methods (Design of Experiments, ANOVA) and software (Minitab, JMP).
- Familiarity with GLP, cGMPs, 21CFR820.30, ISO, and ASTM procedures.
Eligibilities & qualifications
- Bachelor’s or Master’s degree in Mechanical, Biomedical, Chemical, or a relevant engineering field.
- Relevant experience in combination product or medical device development and/or testing.
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