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Packaging Engineer II

Saint Paul, MN 55102

Posted: 02/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 540430 Is job remote?: No Country: United States

Job Description


Target PR: 45-55 commensurate with experience

This is an non-exempt position.

Duties:
  • 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.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Experience:
  • 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.
Requirements:
  • 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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