Summary/Purpose of Position

High level technical position requiring application of extensive technical knowledge to independently lead the design of complex packaging systems in support of:

• Development and commercialization of new products and line extensions
• Manufacturing maintenance-of-business activities
• Cost Improvement Programs

Additional responsibilities may include project leadership and mentorship/supervision of junior level engineers and co-ops.

Essential Duties and Position Responsibilities

Support new product team and line extension activities including:

• Concept development
• Project Plans/Schedules
• Design reviews and design for manufacturability
• Development of test plans
• Development of prototype packaging/tooling

Plan and coordinate all 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 of labeling
• Development and release of all new product and process documentation including design control documentation
• Creation of all relevant test protocols and technical reports
• Planning, ordering and coordination of all new component inventory
• Qualification and validation of all new components, equipment, processes and operations
• New product cost estimates for packaging
• Preparation of AFE(s)
• Evaluation and recommendation of new materials

Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including:

• Development and management for packaging requirements of the transfer plan
• Development and release of all packaging documentation
• Creation of all relevant test protocols and technical reports

Provide packaging engineering support to manufacturing including the following:

• Assessment and development of action plans to overcome packaging related manufacturing issues
• Support of cost improvement programs and manufacturing improvement plans related to product packaging
• Audit support

Provide technical leadership for:

• Technical initiatives, CAPA resolutions, compliance projects
• Due diligence teams to support New Business Development/acquisition teams

Qualifications, Knowledge, and Skills Required:

• B.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of eight (8) years in packaging engineering and design, or M.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of six (6) years relevant experience
• Experience in the medical device or pharmaceutical industries preferred.
• Ability to handle a variety of assignments at the same time.
• High level of written and verbal communications skills.  Ability to write and independently analyze results of technical reports.
• Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
• Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.
• Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.
• Working knowledge of package test methods, process validation, bar coding and international standards.
• Some travel required as needed to support projects