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 developmentProject Plans / SchedulesDesign reviews and design for manufacturabilityDevelopment of test plansDevelopment of prototype packaging / toolingPlan and coordinate all activities to launch and commercialize new products and line extensions including :
Concept and development of packaging methods and processesCoordination of all new tooling and equipmentCoordination of labelingDevelopment and release of all new product and process documentation including design control documentationCreation of all relevant test protocols and technical reportsPlanning, ordering and coordination of all new component inventoryQualification and validation of all new components, equipment, processes and operationsNew product cost estimates for packagingPreparation of AFE(s)Evaluation and recommendation of new materialsPlan 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 planDevelopment and release of all packaging documentationCreation of all relevant test protocols and technical reportsProvide packaging engineering support to manufacturing including the following :
Assessment and development of action plans to overcome packaging related manufacturing issuesSupport of cost improvement programs and manufacturing improvement plans related to product packagingAudit supportProvide technical leadership for :
Technical initiatives, CAPA resolutions, compliance projectsDue diligence teams to support New Business Development / acquisition teamsQualifications, 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 experienceExperience 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
