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o Development of finished and transitional device packaging, components, labeling and assemblies for sterile, implantable drug/device combination medical devices. o Develop, test, and implement packaging and labeling for products in conjunction with Product Development, Marketing, Regulatory and Manufacturing. o Coordination and communication of packaging technology and designs with project teams as part of the phase review development process. o Documentation activities associated with the qualification and release of the package designs. o Manufacturing process development and support for packaging assemblies. o Work with product managers and engineers and other key teammates to develop product packaging requirements and concepts. o Work directly with outside suppliers for package design development. o Responsible for all technical aspects of packaging from product concept through marketing engineering and validation. o Document all packaging and labeling design, development, and testing to comply with FDA design control regulations. o Lead development efforts for new packaging technologies/materials/equipment. o Assists with other duties as requested. Requirements