Experience

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  Grace infrastructure pvt ltd

  Aug 2015 - Mar 2019

  New product development engineer

  • Forging, Power Press tool design for NPD / CCM using Solidworks and AutoCAD and Responsible for Process design and to ensure APQP phases were captured as per guidance in AIAG manual.• Preparation of Proposal drawings, TRP internal, Master drawings, Quality plan, Control Plan, Process Flow Diagram and PPAP based on NPD, Customer request and ECO / ECN changes.• Working experience on PFMEA by following up Occurrence data, recommended action from manufacturing, analysing monthly review, and brainstorming with second level CFT.• Working for Quality and System improvement through Change Management flow, Document and Data Control flow, ISC flow and NPD flow.• Knowledge of the IATF16949:2016, ISO/TS 16949:2009, JIS, DIN Standards related to fasteners.• Workflow knowledge of SAP regarding Inspection plan, Routing, Planning, BOM and Material creation. Show less

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  Hcl technologies

  Mar 2019 - Jul 2022

  Lead engineer

  • Responsible for Project planning. Handling Change packages from Initiation to Implementation phase and creating Impact assessments by reviewing, updating, and studying DHF, DMR and Requirement documents.• Supporting on Development of 3D models, Drawings, BOM, Test plans, Part Specifications for Medical devices and maintaining these documents in Teamcenter by updating / Routing through Workflow processes.• Development of Caseworks, Mechanical sub structures, Pumping Subsystem design of Infusion pumps by conducting mechanical calculations, Material comparisons etc based on Change request.• Handling DHF Integrity of medical products, 5 major design control elements (Design input, Design output, Design verification & validation, Risk management and Traceability matrix) per FDA, 21 CFR part 820.30 and exposure to medical device standards: ISO 13485, ISO 14971, ISO 15223, IEC-61010 and IEC 60601.• Verifying requirements documents and writing test cases in Microfocus ALM for New pump platform.• Conducting studies by generating protocols for verification testing activities and Test Method Validation.• Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies and Capability Studies (CpK).• Responsible for creating / updating DFMEA, PPAP, HDD documents and Handling 3D models, assemblies, drawings in EPDM(Solidworks) and Windchill (Creo).• Managing team members and assigning day to day activities by daily meetings, Cross function with otherteams as a part of Project management and conducting / attending calls with Clients, Suppliers for SNC, Onshore team regularly for status updates, queries, and presentations. Show less

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  Tata consultancy services

  Aug 2022 - now

  Senior engineer

  • Responsible for design control in NPI, Sustaining project and lifecycle management quality assurance.• Working with all CFT to develop quality engineering documentation independently to lead theirimplementation (Process and Product).• Defining and reviewing risk requirements as per ISO 14971 for the product within design process andupdating DFMEA.• Working on DHF files, Work Instructions, Guidance documents, Forms, Implementation Strategies etc.• Dealing with external suppliers for documents translation by providing PO, Quote request till projectcompletion.• Ensuring product development processes and its documentation meet QS requirements in relevantregulations.• Responsible to improve design efforts over the continuum of product development through Value creation.ideas / Cost saving ideas. Show less