Monisha Mohan Email & Phone Number

Warsaw, Indiana, United States

Warsaw, Indiana

•Conduct Health Hazard Evaluation Determination based on global complaints, regional sales and distribution data •Analysis and evaluation of post market surveillance results for initiation of Health Hazard Evaluation, Issue Evaluation and/or CAPA•Review and analyze surgical techniques and product GD&T drawings to ensure compliance with FDA regulations •Initiate Product Hold based on risk assessment per Global Standard operating procedures, Zimmer Work instructions etc.•Study of Blue Prints, Design Failure Mode Effects and Analysis (DFMEA) and Process Failure Mode Effects and Analysis (PFMEA) for verification and Validation of design inputs per User need •Remediate medical device documents such as Risk management files (RMF), Design History Files (DHF), Design control Tractability matrix (DCTM) complying to Quality System Regulations (QSR) and ISO 13485 and ISO 14791 standards•Work with Cross functional Teams to maintain the consistency in the design control process with development, quality, regulatory and marketing departments

Arlington

Working on multiple projects involving Fluent and Fracture Mechanics. Learning and Researching on Various Levels of Electronic Packaging.

Master'S Degree, Aerospace, Aeronautical And Astronautical/Space Engineering

Bachelor Of Engineering - Be, Aerospace, Aeronautical And Astronautical Engineering