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Engineer Quality

Warsaw, Indiana, United States
March 13, 2018

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Ishan Rastogi

*** ****** *** *** * Warsaw IN ****0 ● +1(469)***-****●


• Motivated, driven and result oriented Mechanical Engineer with a blend of analytical, research and leadership experience

• Seeking challenging opportunities in Medical Device Industry PROFESSIONAL EXPERIENCE

ZIMMER BIOMET (Contract via Advanced Clinical) Aug 2017 – Present Quality Engineer – Data Analytics, Product Surveillance

• Working with different functional teams in processing Complaint trending for expediting HHED/HHE/IE/CAPA/SCAR/DHF requests within stipulated timeframe

• Assisting the team with Monthly Complaint trending for different ZB business segments THE UNIVERSITY OF TEXAS AT DALLAS Sept 2015 – May 2017 Graduate Student Assistant

• Worked under Dr. Tadesse on building, assembling and testing a Humanoid Bio-Medical Robot System (HBS)

• Assisted the professor in grading assignments and exams for Computer Aided Technology (CAD) TATA CONSULTANCY SERVICES LTD Oct 2011 – July 2015 Product Design Engineer/Quality Assurance Engineer (Client: Smith and Nephew, Inc.)

• Designed 2500+ Patient Matched Cutting Blocks using 3D CAD modeling for Knee replacement surgery (TKA)

• Increased the volume from delivering 50 jobs/week to 500 jobs/week by automating and optimizing the process

• Trained and mentored 10+ new trainees on Patient Matched Instrumentation

• Developed, maintained and established project plans and processes for managing annual ISO13485 certification

• Facilitated Audits and Management Reviews to keep the project/account compliant with ISO 9001:2008 and ISO13485

• Established Process Improvement initiatives employing PDCA techniques improving deliverable quality by 35% Quality Engineer (Client: Medtronic)

• Analyzed and reported Complaints/Adverse Events as per US FDA MDR standards (21CFR Part 820)

• Cleared Client’s backlog by optimizing the process and reducing the complaint cycle time by 50% Intern - New Product Development

• Trained and certified on various concepts of New Product Development (NPD)

• Designed a new product using NPD methodologies including VOC, QFD, FMEA, DFMA and Value Analysis/Value Engineering SKILLS

CAE Packages: UG NX, Pro-E/CREO, SolidWorks, ANSYS, MATLAB, AUTOCAD, MS Office/Access/MS Project Quality Standards: ISO13485, ISO14971, ISO 9001:2008, US FDA MDR, FDA 21CFR Part820 Methodologies: NPD/NPI, GD&T, FMEA, CAPA, Lean, Six Sigma, Project Management, Process Improvement, Risk Management, Complaint Management, Trending & Analysis EDUCATION

Master of Science, Mechanical Engineering May 2017 The University of Texas at Dallas (UT Dallas), Richardson, TX GPA: 3.75 Bachelor of Engineering, Mechanical Engineering June 2011 Visvesvaraya Technological University, India


Efficient utilization of Man Machine and Inter Machine Interaction in a FMS Feb 2017 – May 2017

• Analyzed multiple Flexible Manufacturing Systems (FMS) and optimized one for maximum efficiency The Pareto Managerial Principle Feb 2016 – May 2016

• Performed a case study by applying Pareto Principle in critical Managerial decision making

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