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This position is responsible for drug delivery systems or combination product test method development and validation with minimal supervision. The candidate will develop tests, including but not limited to, Design Characterization and Design Verification.
Job Responsibility:
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
Requirements:
1-5 years of experience in combination product or medical device development and/or testing, with a Bachelor's degree
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
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