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8 Adams ln Downingtown PA Street Address Cell :PHONE NUMBER AVAILABLE Email:EMAIL AVAILABLESummary Total 22+ years of experience in Medical Devices and Healthcare Industry, Automobile, Off highway and Construction Equipment, and Agricultural Equipment. International Experience in India, the United states, Costa Rica, Panama, China and Mexico More than 20000 hours of experience working as a CAD engineer working on Automobile, Off-highway vehicles, agricultural equipment, construction equipment And medical devices Onsite Experience at DePuy Synthes Power tools , Palm Beach Gardens, FL,USA Design control support to assure continued compliance to ISO 13485 quality system as well as EUMDR 2017/745, USFDA 21CFR and other international regulations. Onsite Experience at DePuy Synthes , West Chester, PA,USA Product portfolio management ,Design transfer possess in depth knowledge of project status, issues and interdependencies across the portfolio Onsite Experience at Medtronic, Mansfield, MA,USA Lead Product identification and data standards ,work directly with strategic Project management, Complete barcode verifier and print process validations, update purchase specifications and inspection requirements for FDA and UDI compliance. Onsite Experience at JLG Industries Inc, Orrville, OH , 2 Years, Design and development activities for the development of various frames, Hydraulic and electrical packing of components of the Telehandler machines More than 8000 hours of experience working as a Manufacturing engineer working New product launch, Sheetmetal stamping, Brazing, weldment for automotive and construction industries More than 8500 hours of experience working as an onsite (In USA) engineer supporting New product development, Sustenance engineering, Build incident and Test incident support, validation, design and Design transfer Experience in various phases of New Product development namely Concept Design, Detail Design, Prototyping, Product manufacturing, Design Verification and Validation and Component qualification. Expertise in using statistical concepts such as data transformations, distribution analysis, capability analysis etc. Experience in concept development, Harness routing, Tube routing, product design optimization, for Agricultural Equipment, construction equipment, Industrial products and heat exchanger parts, extensively worked on sheet metal design, weldment & assembly design (top down and bottom up approach). Supplier co-ordination and developing manufacturing processes at supplier.(Process capability acceptance) Effective usage of design tools like DFMEA, DFM, DFA and Bench marking. CAPA, ECO, Specification Matrix, engineering. Lead equipment qualifications and develop validation strategies for Medical Supply and Surgical sites across USA and remote support to Europe and Asian countriesProfessional ExperienceHCL America Solutions INC (Consulting to DePuy Orthopaedics Inc Subsidiary of Johnson& Johnson) West Chester PA USA Aug 2021 to till DateProject Manager Case And Trays -Design transfer for 240 Case assembly codes Product portfolio management possess in depth knowledge of project status, issues and interdependencies across the portfolio Propose strategies to client and offer solution Participate in Business development and relationship management. Support and deliver the metrics around quality, service and value for lifecycle projects. Delivery & Program Management on-site & off-shore based outsourcing business model. Create and complete technical file submissions; communicate with authorities regarding these submissions. Review Quality plan by vendor to address all specific need for Functional to quality and critical to quality Review suppliers Capability for the parts, Visit site and review all necessary documentation related to manufacturing Review drawing prints to address challenges by supplier (To utilize their existing tooling, program set up and assembly fixtures) Access Engineering changes asked by suppliers for smooth production Review First Article made by supplier and test according to the performance needTechnovators Inc -(Consulting to Depuy Synthes Power Tools Subsidiary of Johnson& Johnson) Palmbeach gardens FL USA Nov 2019 to Jul 2020Project Manager
New Product Development, Engineering Change Management, EUMDR/ UDI compliance systems and process gap analysis
Support product labelling initiatives such as the bar code implementation, harmonized symbology implementation, Managed Change execution of medical device, Direct part marking for UDI and new CE mark, Both projects were completed ahead of schedule, Done Design of experiments to adjust marking on the parts Established Project for the change execution of medical device label and IFU changes required by EU MDR regulations for over 400 products. Developed Key Functional Elements and restricted substance documents for the current parts to comply with EUMDR requirements. Address line stoppage issue due to program error with the production line Remediation of manufacturing, repairs and inspection procedures for Anspach and Synthes products Assessed current Equipment Qualification, Process Validation, Test Method Validation (TMV) System, procedures and practices and contributed to the development of new procedures, protocol/report templates, test methods and remediation/validation activities and improvement
L&T Technology Services LLC(Consulting to Medtronic) Mansfield MA USA Nov 2015 to Nov 2019Project Engineer UDI and SAP implementation (Validation & verification) Kick of SCR with contract manufacturer Work as part of a cross-functional team that is rolling out product identification and Data Standards across the company. Involve in project coordination for product identification and Data standards at identified sites Conduct quality planning activities in support of project implementation. Work directly with the manufacturing plants and contract manufacturing sites on integrating corporate protocols into site quality systems.
Conduct Design of Experiment with the supplier and Distribution center to get proper set up for the printer which will give consistent results of production Plan and organize the work of a project team, develop the implementation strategies for projects, act as a mentor for individuals within the group, and resolve issues within project teams Responsible for hands-on execution of validation protocols and write summary reports.
Review and update product purchase specifications and bill of materials Collect evidence demonstrating appropriate process controls have been implemented Responsible to identify constraints that impact schedule. Support CAPA and Change order with model and drawing change by using Creo 2.0,Review GD&T and conduct tolerance stack up based on need.L&T Technology Services LLC(Consulting to JLG industries Inc) Orrville Ohio USA Jan 2014 to Oct 2015Onsite Design Engineer and Co-Ordinator Concept work for integrity requirement of electrical, powertrain,hydrauilic systems The Purpose of the project is to support new component development for Class C frame including Hydraulic, electrical and powertrain component packaging, (Here we need to use most developed current components and standard components available in the market) Involved in design change (new concept) of components failed in FEA Design review with Project engineer. Create ideas to make installation drawings for easy assembly Applied GD&T to components and assemblies by using references top to down. Support all frame design activities like Heavy weldments, component packaging, off-road durability, flexibility/stiffness, weldability, drainage, stress concentration minimization, cost/value, assemble-ability, parts minimization Provide technical assistance for prototype, pilot and production support, eBOM specially with build in incident report and test incident report Develop necessary fixture to hold component during welding and assembly Route Hydraulic lines(Soft and hard),And Harness to accommodate and fulfil configuration need for the machine Hands on experience in creation of CAD model from scanned data or point cloud data for various parts. Proficient in various modules of Pro/Engineer like Pro/Piping, Pro/sheet- metal, Pro/Surface, Pro/Cabling and technical simulation tools like Pro/Mechanism.
Interface with FEA and make and suggest modification to component based on stress analysisL&T Technology Services LLC (support to CNH,JLG,Peierce,Komatsu..) Vadodara Gujarat India Jul 2010 to Dec 2013Offshore lead Identifying the changes because of engine replacement in different technology areas. Some of these areas included following. The purpose of this project was developing Concept, create workable assembly, hydraulic route, harness route solid and sheet metal models and drawings Interaction with onsite engineer or Project Engineer for designed concepts, solving queries related to work. aPriri costing done for comparing Proposed model with current model
Looking for Quality check of all drawings made by team,(always check drawing completeness for manufacturing and assembly prospect) Supported in identifying the components for sheet metal to plastic conversion. Support Manufacturing challenges faced after drawing release Checking the Drawing as per Client Set Standards 3D Model creation for tubes and hoses as per the 2d drawing received and Client Set Standards 3D Model creation with Skeleton modelling (Top Down) approach.Banco Products (I) Ltd
Vadodara Gujarat state India Oct 2004 to Jun 2010 Mechanical Engineer Tear down Engineering of Imported Parts using Advanced Measuring Instruments like CMM, 3D Scanner (FARO), Profile Projector, and Contracer etc. Active member in TS 16949 & Six Sigma projects Worked with vendor for solution on testing and validation Developed plastic workable models (Total created 40 plastic tank model in Proe) for radiator tanks Experience in manufacturing Facility planning like Layout creation for productivity, Process sequence to get best result Capacity Planning to meet future production enhancement, Tool try out approval for new tool (Provide suggestion for Fool proofing, Review correct installation of equipment s & machineries Value engineering suggestions to the the production line (Tooling management, handling, Automation ,Cycle time reduction, SOP creation, New member training manual creation etc.
Supported on the shop floor Engineer (handling 12 machines and 30 peoples) Worked for process control plan and implementation and design of experiments for tooling,
Carried out SMED for reducing change over time for the tooling Prepared DFMEA, PFMEA and control plans for improving the prototype and experiments results Carried out simulation study prior to launch new model production and assemblyJai Bhavani Engineering works Botad Gujarat state India Jun 2002 to Sept 2004 Trainee Engineer Support manufacturing, Quality and planning activities for bearing manufacturingReferences Available on RequestEducationBachelor of Engineering (Mechanical)#Equivalent to US Bachelor of Science degree in Mechanical EngineeringCertifications and AwardsCertified Project Management Professional (PMP )-Project management instituteCertified Scrum Master(CSM ) Scrum Alliance
Technical Skills MS Office,Minitab 17,aPriori Costing,MS Project,Visio,Catia V5,Creo Parametric 7.0 Autocad 2006,Windchill,Team center,Agile,Document locator,Solidworks,Bartender Label view, |
