Packaging Engineer # JN -042021-62039
Little Canada, Minnesota
Posted on: April 1, 2021
Industry: Database Administrator / Engineers
Job Number: JN -042021-62039
Position Title: Packaging Engineer II
Location: St. Paul, MN
- Manage and execute packaging changes to drive margin improvements, while ensuring current state performance, Specify, design, verify and validate packaging in accordance with applicable medical regulatory standards.
- Develop packaging specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements through completion. Prepare Quality Plans, Design Change Plans, Master Validations Plans, protocol, and written reports.
- Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis. Evaluates process and design alternatives based on “design for manufacturability” principles.
- Troubleshoots to determine optimal run ability of packaging. Communicate effectively and participate on cross functional development teams. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Packaging specification development, Packaging testing for all types of packaging including cartons, corrugate, labels, pouches, thermoform trays, etc. Development of qualification protocols for the medical device/pharma industry.
- Experience in sterilization processes and protocols, Proficient in reading and creating engineering drawings, including dimensions, tolerances and schematics, Excellent working knowledge of writing protocols, preparing testing samples, testing samples, and making strong conclusions.
- Excellent firsthand working knowledge medical device package testing as well as proficient working knowledge of ASTM standards associated with medical device package testing.
- Packaging Engineer by education/experience, BS in Packaging, Mechanical, or Manufacturing Engineering, 5-10 years packaging industry experience, 3-5 year in med device/pharma industry, Proficient and extensive working knowledge of packaging equipment for all related processes, Proficient and extensive working knowledge of packaging material and suppliers processes. Subject matter expert of ISO 11607 part I & part II
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