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Associate Scientist I / II
* Provide a fundamental knowledge in the areas of material structure, properties, processing, performance and inspection.
* Predictively screen materials for primary packaging, devices and secondary packaging, and make recommendations for selection.
* Develop test methods for materials characterization and set specifications as needed.
* Assess changes in materials or manufacturing processes on primary pack and device performance.
* Apply regulatory guidance and industry standards to materials/device evaluations and development.
* Generate and maintain Design History File documentation for multiple device projects.
* Support the design and development activities for multiple device projects.
* Participate in problem solving and trouble-shooting activities related to primary packs and devices.
* Contribute to regulatory submissions by authoring relevant sections related to materials.
* Maintain awareness of recent technical developments within packaging and interact with component vendors as required.
* Present data at various project team and department meetings as needed.
Requires knowledge and previous experience within the areas of materials science/engineering and the design and development of medical devices. A good understanding of the pharmaceutical/biopharmaceutical industry and experience within biotech is preferred. Experience with commercial/clinical development and/or regulatory filings related to materials and device development are an advantage.
B.S. or M.S. degree in Mechanical/Biomedical/Chemical Engineering or related field, with 5-10 years of experience with a B.S. or 2-8 years of experience with an M.S., in the medical device, pharmaceutical or biotech industry
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BioTech FYI Center