Overview: This company is a leading developer,
manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 4 decades, they have stood
out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized
surgical procedures, fixation and biologic implants. In addition they have a growing line of enhanced sealants and hemostatic
products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.
The Packaging Engineer II or Senior Packaging Engineer,
depending on the experience you have, 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
Essential Job Functions:
Packaging Engineer II
- Provide cross-franchise support for new product development and line extension
- 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:
and development of packaging methods and processes
- Coordination of all new tooling and equipment
and support of all new vendor tooling and artwork
- Development and release of all new product and process
- Generation of packaging specifications and associated documentation
of packaging test plans
- Planning, ordering and coordination of all new component inventory
and validation of all new equipment, processes and operations
- New product cost estimates for
- Preparation of AFE(s)
- Evaluation and recommendation of new materials
and manage all packaging engineering activities to transfer new products and line extensions to manufacturing
- Development and management of packaging requirements to support the transfer plan
and release of all packaging documentation
- Special projects as assigned.
Senior Packaging Engineer
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
Education: Requires a Bachelor's degree in Packaging Engineering or Science, Life Sciences or other Engineering
- 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.
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.
- Determination of level will be based upon years of experience and demonstrated