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Packaging Engineer

Fusion Life Sciences Technologies LLC
Irvine, CA Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/17/2025

A leading Medical Device client in Southern California is in immediate need of a Packaging Engineer for a 12-month project. This is an on-site position. This Packaging Engineer will be responsible for design creation and innovating packaging of new products / processes and lead their implementation.

Requirements :

  • BS Degree Minimum
  • 5 years of medical device packaging design and development experience
  • SolidWorks design software
  • Experience with Artios CAD would be an additional plus
  • Experience with Sterile Barrier and Medical Device Packaging development, ideally Tyvex based packaging designs, including trays and pouches
  • Must have experience with ISO 11607 Part 1 and 2
  • Experience with design verification and validation of primary, secondary, and tertiary packaging designs for Class II or III medical devices

Essential Responsibilities :

  • Prepare packaging validation protocols and reports to support packaging changes.
  • Perform packaging validation testing to support changes.
  • Develop Packaging Validation protocols to ensure compliance with ISTA and ASTM standards
  • Create and update packaging specifications for manufacturing.
  • Assist in artwork creation and revisions for product packaging.
  • Operate various testing apparatus in qualifying packaging changes.
  • Provides work direction to lab technicians as required.
  • Prepare and execute packaging validation protocols, including reports, to support packaging changes.
  • Perform packaging validation testing to support changes.
  • Create and update packaging specifications for manufacturing
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