Job
Description
Role & responsibilities: Fully participates in and successfully contributes to project teams typically including the following activities: Packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation. Generate, evaluate and coordinate packaging related documentation including specifications, test plans/reports, and other BSC Product Development Process documents. Strong knowledge of statistical methodology. Evaluate, create and document package/product test methods for new product development and existing design improvements. Understanding of documentation management systems and good manufacturing practices (GMPs) is required. Work closely with other members of the Packaging Engineering department and interact with personnel from a variety of areas within BSC. Develop strong team skills, including communication, teamwork, initiative and managed execution of all project deliverables. Work with suppliers and OEM contacts to establish partnerships to maximize quality, delivery, and lead times, and to incorporate their abilities, ideas, and material/product knowledge into new development. Responsible for coordination/creation of the formatted Directions for Use Responsible for the coordination of translations for labeling and Directions for Use using translation vendors. Responsible for review and Change Request activities for the approval and release of labeling, Direction for Use and other packaging components. (example: CN process in Windchill) Responsible for creation of new, and changes to, miscellaneous packaging components based on preexisting formats and design Keep abreast of new technologies, test methods and advances in the medical device packaging industry. Skill Set: Must have - Packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation. Evaluate, create and document package/product test methods for new product development and existing design improvements. Tools: MS tools (Excel, Word, PowerPoint, etc.) Statistical Software and its use for Engineering Applications Adobe illustrator, InDesign Key Words: Packaging/product design and development, Test of materials, preparation of specifications, process capability . CN process in Windchill
