Kam Khatkar Email & Phone Number

California, United States

Milpitas, CA

• Managed the manufacturing transfer of new medical devices into production including new line design / setup, MVPs, PFMEA and Manufacturing Instructions.
• Created and updated documentation including Manufacturing Instructions (MI’s), Test Methods (TM’s) and BOM’s. Implemented Change Orders (CO’s) into Agile.
• Generated and performed IQ on new Test Fixtures into production.
• Reduced the cost of the existing Cataract machine by 10% by converting viable machined parts into 3D Printed Parts.
• Formulated and executed Test Protocols to validate the new 3D Printed Parts.
• Designed and released Serial Number Labels on EasyLabel software used on capital equipment and packaging.

Mountain View, CA

• Managed the introduction of multiple new Medical Devices into Production while successfully meeting or exceeding tight project deadlines.
• Completed Process Flows, Manufacturing Process Instructions (MPI’s), Test Instructions, Material Planning, Tooling, Testing and DCN Project Management resulting in timely New Product Introduction (NPI).
• Researched and closed out CAPA’s and Complaints resulting in a 50% decrease in the number of open complaints for the manufacturing engineering department.
• Created and executed IQ / PQ for mechanical assemblies outsourced to contract manufacturers resulting in rapid introduction into production.
• Created and implemented Engineering Change Orders (ECO’s / DCN’s) to decrease costs and improve the manufacture of Hansen Products.
• created and sustained Engineering and Manufacturing Bill of Materials (BOM’s) for New Products.