Job Description

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
• Ensure packaging designs meet FDA and ISO requirements.

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