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Packaging Engineer
Ref No.: 18-27958
Location: Franklin Lakes, New Jersey
Position Type:Direct Placement
Start Date: 04/23/2018
· Product Design / product sustenance experience
· Packaging design, development & change qualification
· Knowledge on standards and regulatory requirements for various regions
· Labeling and Packaging requirements for various regions / markets
· Technical (report) writing
· Basic Mechanical Engineering
· Change control Management
· Design verification
· Statistical analysis (Minitab)
· ISO 13485 / FDA Guidelines
· GD&T
· Prototyping
· Solidworks, TOPS pro (or any pallet configuration tool)


· Support in design & development of all levels of Medical device packaging with due consideration to safety, subsequent processing, environment & shipment logistics.
· Support new product development and Sustaining Engineering of Medical device packages & associated Project management
· Follow standards such as ISO13485 / QSR 21 CFR part 820
· Carryout Engineering change management & Design Control activities of Medical devices
· Carryout Root cause analysis and work on NC/CAPA resolution of Medical devices
· Develop Design Verification strategies, traceability matrices & associated requirements
· Develop understanding in functional / system testing of medical devices
· Perform CAD modeling and drafting using Solidworks with proper GD&T. Perform Palletization and Nesting configuration modeling and drafting using TOPS pro software.
· Technical writing – Design Verification Plan, protocols and report preparation, MSA
· Self-Motivated Team Player / coordination skills between offshore and onsite

Education Qualification:

· Bachelor's / Master's degree in Packaging or Mechanical Engineering