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MILLENNIUMSOFT

Packaging Engineer II

MILLENNIUMSOFT, Warwick, RI, United States


Job Title: Packaging Engineer II

Location: Warwick, RI

Duration: 12+ Months

Description:

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.

Essential Job Functions:

Packaging Engineer II

1. 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

2. 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

3. 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

4. Special projects as assigned.

Senior Packaging Engineer:

All the above as outlined under Packaging Engineer II.

In Addition, provide technical leadership for:

• 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

Basic Qualifications:

• 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.

Additional Desirable Qualifications:

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