Sr. Packaging SME

Boston, MA

Industry: Quality Job Number: 120107

Sr. PackagingSME


Our client is a large Medical Device organization that develops and manufactures a number Medical Devices. Our client is currently having issues with their packaging designs and configurations, and Packaging Validation documentation. Due to Packaging Design problems in recent years they have transitioned from hard trays with Tyvek lids, to Pouch packaging, but they are still failing shipping tests. They are in need of a Sr. Packaging Consultant to assess the current design problems, and to suggest/develop new alternative packaging designs, and create Validation documentation/legacy validation.



The Sr. Packaging Consultant will be responsible for a complete gap analysis of the current Packaging Designs, and to either remediate design issues/suggest and develop alternative Packaging Designs that will pass shipping tests, and conform to FDA standards: cGMP, 21 CFR Part  820 (Subpart 130). The individual will be working with the R&D team, and should have extensive Packaging Design & Development, and Packaging Validation  experience in the Medical Device space. They should be able to assess the products and their current packaging designs, and to bring in alternative packaging methods to pass Shipping Tests.

This individual will need to understand the logistics behind shipping/distribution in order to properly assess risks and to perform a successful gap analysis. They will have an integral role in supporting Packaging R&D and Sustaining Engineering.
  • Gap Analysis on Packaging
  • Packaging Validation & Legacy Validation
  • Develop and implement new and product packaging specifications, documentation standards, procedures/processes/systems,  testing protocols and development guidelines
  • Support packaging improvements, gap analysis on existing packaging operations, and developing/optimizing packaging designs 
  • Conduct data analysis and interpret results

  • Medical Device: 10+ years
  • Packaging Design & Development
  • Packaging Validation
  • Gap Analysis/Remediation of Packaging Methods
  • Design Controls
  • Shipping & Distribution

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