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Packaging Engineer
Ref No.: 19-10580
Location: Morrisville, North Carolina

Job Description                                                                                                                     

·         The Packaging Engineer will work closely with cross-functional teams to meet the compliance of medical device packaging as per ISO 11607 and EU MDR requirements

·         3-5 years in packaging engineering (Medical devices or Pharmaceuticals)


·         Master of Science (MS) OR Packaging Science Degree OR Masters in Mechanical Engineering OR Masters in Biomedical Engineering OR Bachelor in Biomedical Engineering

Required Skillset(s)                                                                                                             

·         Detailed understanding on ISO 11607 and EU MDR packaging & labeling requirements

·         Extensive understanding and practice of ASTM and ISTA testing standards

·         Experience in creating protocols and reports for packaging Design Verification Studies

·         Experience in creating Engineering Change Requests for packaging for design changes

·         Review and approve all packaging/labeling specifications and other technical documentation

Preferred Skillset(s)

·         Experience in writing regulatory Rationales

·         EU MDR Labeling & Packaging Experience

·         Detailed knowledge and Experience in Medical device packaging test methods

Day to Day responsibilities

·         Need to work on Sterile as well as Non sterile medical device packaging
Day to Day co-ordination with Offshore team members