- H1B Visa holder.- Graduate Mechanical Engineer with a total of 14 years of experience.- Working onsite at client location Medtronic Inc. - Currently in New product and process development, Supplier quality Engineering, Design V&V and professionals in Manufacturing Technology.PROFESSIONAL SYNOPSIS:● Leading the team responsible for Product life management by ensuring the performance of the product in Design verification and lead the project till closure, interaction with customer’s R&D, Quality to finalize requirements.● Expertise in IQ, OQ and PQ procedures with developing DV plan, protocol, test methods and final reporting using ASTM and ISO standards.● Expertise in Medical components knowledge.Perform design verification activities and prepare design verification reports.● Perform design review functions based upon CFR Part 820 standard.● Responsible for the complete process of developing Automobile and Firearms products from inception to finished product using APQP and DFSS tools to deliver high quality products to customer.Responsible for Conceptual designing of gauge and fixtures for the components.● Expertise in deriving the Optimum Process Flow and manufacturing process for the product using DOE.● Responsible for planning the machines, layout design, lead time calculation of the particular product and also responsible for estimating the process and product cost for the new RFQ parts.● Responsible for preparation of PPAP, APQP documents, PFMEA, Control Plan for various products.TECHNICAL EXPERTISE:● Expertise in Material testing (Tensile, compression, torsion test etc.)● Test Method Validation (TMV). ● Product testing (Assembly/closing force measurement, Disassembly/opening force measurement, leakage test, Drop test, IP Test etc.). ● Good knowledge on the ISO 13485 & CFR Part 820.● Knowledge in Tolerance stacking and Analysis.● Expertise in Metal injection molding, Plastic Injection molding.● Gauges, Jigs & Fixtures concepts development.● Six Sigma Green Belt holder and implemented a project in Indo Us MIM Tec.l● Knowledge in GD&T, DOE, SPC & QC tools,CAPA.● In depth Knowledge in route cause analysis using 7QC tools.● Skilled in Project management and risk assessment activities.