Sanjeev Kumar G.
Senior Packaging Engineer @ Medtronic
About
Senior Packaging Engineer
United States
Denver Metropolitan Area
Medical Device
IVDR, Labeling, Microsoft Excel, Sustainable Packaging Design, Packaging process, Plastics films, FFS, U.S. Food and Drug Administration (FDA), MDR, ISO Standards, Graphic Design, Creative Problem Solving, Adobe Creative Suite, Medical Device Product Development, Microsoft PowerPoint, Autodesk Inventor, SOLIDWORKS, Unigraphics, Catia, GD&T
Experience
Senior Packaging Engineer
Medtronic
United States
Senior Technical Lead
HCLTech
United States
Senior Technical Lead
HCLTech
Chennai, Tamil Nadu, India
Technical Lead
HCLTech
Chennai, Tamil Nadu, India
Packaging & Labeling Coordinator
Siemens Healthineers
Norwood, Massachusetts, United States
• Understanding GSPR requirements for IVDR labeling. • Gap assessment on the labels and IFUs with respect to EU IVDR 2017/746 regulations. • Redlining of Labels and IFUs against the gaps assessed through GSPR. • Update to labels and IFU from the redlines. • Complete impact assessment and change control process until the release of • labels to production. • Addressing notified body queries on labeling. • Prepare all the labeling items for CE certification. • Packaging and labeling remediation compliance to EU-IVDR. • FDA 508 compliance PDF creation for COVID IFU and make the PDF accessible. • Compliance to France specific recyclable symbols to the recyclable cartons • marketed to France. • Compliance to Swedish regulations
Packaging & Labeling SME Support
Abbott (through HCL India)
Irvine, California, United States
Packaging & Labeling SME Support
Haemonetics (through HCL India)
Boston, Massachusetts, United States
Packaging Engineer
Johnson & Johnson MedTech
Irvine, California, United States
R&D Packaging Engineer
Becton, Dickinson and Company (Through HCL)
Franklin Lakes, New Jersey, United States
Design Engineer
invilogic
Mechanical Associate Engineer-I
Dell Technologies
Senior Design Engineer
Cyient
Hyderabad Area, India
Education
Jawaharlal Nehru Technological University
Mechanical Engineering
Sanjeev Kumar G.'s Contact Information
Phone
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