Professional Experience: 9+ Years of experience in Medical Device manufacturing Industry.Currently Working as a Engineering Manager(Projects) at Abbott. Previously worked as Staff Component Engineer at Johnson and Johnson Medtech. Prior to that worked as Process Development Engineer In Abbott Laboratories.As a Process development engineer, I was responsible for establishing processes based on product specifications.Manage programs in compliance with FDA and ISO quality control requirements (i.e. Design Control, Process validation etc.).My role includes working individually and cross-functionally to lead process development of complex technologies on new products, rapid prototyping execution, and ensure efficient and effective transfer of product into production. I have good experience in developing processes for critical medical devices and validating the process to ensure the product design requirement. Major skills job functions are to understand product design requirements, developing process by conducting critical testings,experiments(i.e Design of Experiments(DOE)),analyzing the results statistically using software such as Minitab and Design expert, understand and apply risk assessment tools such as(PFMEA, hazard analysis).developing fixtures and tooling using CAD and simulation soft wares. finding new processes, conducting experiments, collecting data, interpreting existing data analyzing the results, defining process parameters, qualifying equipment(i.e installation Qualification), writing technical reports and IQ protocols, IQ reports. developing inspection procedures and validate test methods(i.e. test method validation using Guage R&R method). Also,process validation( i.e. OQ and PQ), writing final manufacturing process, train and certify operators and technicians.