Responsible for the design, development, and support of package systems for sterile medical devices including components, assemblies, and labels. Position Responsibilities • Development of packaging and labeling components, and assemblies for sterile (sterilized by Ethylene Oxide, Steam, Liquid Chemical, Gamma methods), medical products in support of R&D / new products • Provide technical recommendations and coordinate introduction / implement changes in the packaging process and materials. • Actively collaborate with Packaging and Labeling peers within CardioVascular to identify and implement best practices, packages and processes. • As requested, participate on cross-functional, cross-site project teams focusing on packaging, technology and processes improvements • Utilize knowledge of FDA and ISO requirements related to packaging and labeling, ensuring robust package validation and qualification • Experienced with IQ/OQ/PQ as part of packaging processes • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs • Process development and support for packaging assemblies for manufacturing • Develop plans to establish proof of shelf life (shelf life), accelerated and real time. • Coordinate projects and deadlines working with P&L lead to ensure all new product and package improvement deadlines are met. • Manage various aspects of packaging development and testing as required • Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors. Basic Qualifications • BS Packaging or Engineering (Mechanical or Materials) • Four years packaging experience, with a minimum of 2 years medical device packaging experience. Advanced technical degree a plus. • Experience with automated and/or semi-automated packaging equipment and processes • Knowledgeable in ISO, ASTM, ISTA standards related to packaging. • Solid proficiency in MS Word, Excel and statistical analysis software Preferred Qualifications • Certified Packaging Professional (CPP) preferred. • Experience with data base driven labeling systems • Experience with DFLS, DFM, process development and design of experiments (DOE) methodology