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Packaging Engineer

Company Name:
Premier Personnel Services of New York
The Manager of Packaging Engineering will be responsible for providing technical leadership and functional management of the newly formed Packaging Engineering Group. These duties will include the development, test, and implementation of packaging solutions for new products along with improving existing packages and associated packaging related equipment for medical devices. These packaging solutions will include primary, secondary, and tertiary packages along with the development of in process and final customer shipping solutions.
SUPERVISION EXERCISED
Directly manage 1-3 Packaging Engineers (Junior and Senior Level).
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Provide technical leadership in the development, testing, and implementation of sterile barrier medical device packages, labeling, and shipping solutions for Companys new products.
Provide technical leadership in the package material selection to ensure robust package solutions.
Responsible for leading packaging manufacturing process development activities such as heat sealing or package integrity testing.
Responsible for leading packaging improvement projects for existing packages and packaging related processing equipment solutions.
Responsible for leading the development of robust packaging testing solutions that comply with ISO 11607 and ASTM standards.
Responsible for leading packaging related CAPA initiatives and provide technical input to packaging related NC investigations as the Collagen Packaging SME.
Serve as the technical lead and interface to packaging development, testing, and component suppliers.
Responsible for driving consistency and excellence in the packaging development activities and processes.
Lead special projects as needed.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Minimum BS in Packaging Engineering strongly desired. Other Engineering disciplines will be considered with appropriate level of packaging related experience.
Minimum 10 years of experience in a medical device or pharmaceutical industry.
Minimum 5 years of direct experience in medical device packaging development.
Previous direct management experience of Engineers highly desired. 3 years direct line experience preferred.
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory procedures is required.
Experience in packaging in clean rooms a plus
Deep technical knowledge of ISO 11607, FDA, and ASTM testing standards relating the medical device packaging development and testing.
Knowledge and experience selecting, installing, testing, and validating packaging sealing, labeling, and integrity testing Equipment.
Exceptional practical problem solving, organizational and communication skills,
Microsoft Office software and tools
Experience in characterizing packaging manufacturing process using multi-factor DOE design desired.
Use of statistical process tools (software) highly desirable. Minitab or Statgraphics a plus.
Certified Six Sigma Green or Black Belt highly desired with a preference on Black Belt.

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