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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 team members 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. Qualifications