Packaging Engineer II

Overview: This role will be responsible to plan, organize and coordinate all Packaging Engineering and labeling related activities including development and commercialization of new products; line extensions; manufacturing maintenance of business activities;
Cost Improvement Programs; testing and labeling activities to support ever-changing regulatory and industry requirements, and investigation, evaluation, and implementation of new packaging concepts, materials and systems.

This role will be responsible to plan, organize and coordinate all Packaging Engineering and labeling related activities including development and commercialization of new products; line extensions; manufacturing maintenance of business activities;
Cost Improvement Programs; testing and labeling activities to support ever-changing regulatory and industry requirements, and investigation, evaluation, and implementation of new packaging concepts, materials and systems.

• Provide cross-franchise support for new product development and line extension activities including:
• Concept development
• Project Plans/Schedules
• Design reviews and design for manufacturability
• Development of prototype packaging
• Plan and manage all packaging related activities to launch and commercialize new products and line extensions including:
• Concept and development of packaging methods and processes
• Coordination of all new tooling and equipment
• Coordination and support of all new vendor tooling and artwork
• Development and release of all new product and process documentation
• Generation of packaging specifications and associated documentation
• Development of packaging test plans
• Planning, ordering and coordination of all new component inventory
• Qualification and validation of all new equipment, processes and operations
• New product cost estimates for packaging
• Preparation of AFE(s)
• Evaluation and recommendation of new materials
• Plan and manage all packaging engineering activities to transfer new products and line extensions to manufacturing including:
• Development and management of packaging requirements to support the transfer plan
• Development and release of all packaging documentation
• Special projects as assigned.

All the above as outlined under Packaging Engineer II.

• Creation of test protocols and technical reports.
• Development of action plans to overcome packaging related manufacturing and quality issues.
• Assist with cost improvement programs and manufacturing improvement plans related to product packaging.
• Provide leadership with technical initiatives, CAPA resolutions, and compliance projects

• B.S. Degree in Packaging Engineering or Science, Life Sciences or other Engineering discipline required.
• Packaging Engineer II:
  With a B.S., minimum of 3 years’ experience in packaging engineering and design or with a M.S., minimum 2 years’ experience in packaging engineering and design.
• Senior Packaging Engineer:
  With a B.S., minimum of 5 years’ experience in packaging engineering and design or with a M.S., minimum 4 years’ experience in packaging engineering and design.
• Strong knowledge of package test methods, process validation, bar coding, and international standards.
• Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.
• Previous experience in the medical device or pharmaceutical industries required.
• Capability of handling a variety of assignments at the same time.
• High level of written and verbal communications skills.
• Travel approximately 15% of time.

• Knowledge of FDA and functional requirements for Class II and Class III sterile, non-sterile, disposable and reusable devices.