The ideal candidate can be located in either Warwick, RI or Vernon Hills, IL. The work schedule is in the office Monday - Thursday with a Remote day on Friday.
Summary
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
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