• Responsible for the design, development, and support of package systems for sterile medical devices including components, assemblies, and labels.
• Responsible for the development and implementation of packaging for existing and new medical products and devices including class-II and class-III implantable products, drug/device combination products, and accessories.
• Coordinate introduction / implement changes in packaging, process and materials.
• Provide input on packaging considerations to the device design and development process.
• Work closely with R&D and manufacturing to implement packaging changes. Prioritize and manage multiple projects, leveraging resources to meet project milestones and timelines.
• Responsible for evaluation of materials, design, and configuration of primary, secondary, and other packaging to optimize customer benefit, operations requirements, and the supply chain requirements.
• Consider shipping, warehousing, and supply chain requirements for packaging, recommend improvements and implement the most efficient packaging solutions, considering cost, waste, damage, customer needs, etc.
• Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs
• Perform other related activities and special projects as needed.
• 2-4 years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 0-2 years with MS
• Must be proficient in the use of computers and PC based programs such as Word, Excel, Project, Powerpoint.
• Experience working in a cross-functional team environment.
• IoPP Certified Packaging Professional (CPP) certification.
• Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
• Experience with automated packaging equipment and lines.
• Experience with Solidworks, Agile, and SAP software.
• Experience with process development and design of experiment (DOE) methodology.
• Familiarity with FDA quality assurance requirements for design and manufacturing.
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