Packaging Engineer - Katalyst Healthcares & Life Sciences
Orange, CA 92705
About the Job
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
- BS Degree Minimum.
- 4-8 years of relevant packaging engineering experience required.
- 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.
Source : Katalyst Healthcares & Life Sciences