Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
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KUMARAGURU E

KUMARAGURU E

Verification And Validation Engineer
Chengalpet, Tamilnadu

Summary

To engage in an innovative and challenging environment which enhance my skill where I can contribute to the organization growth and profitability.


PROFESSIONAL SYNOPSIS (Experience: 6 years 2 months)

Verification and Validation Engineer 2 years 4 months of experience in verifying and validating the medical devices product requirements, equipment validation, preparation of product control specifications, laboratory activities and DHF Remediation.

Quality, NPD & Vendor development Engineer with 3 years 8 months of experience in developing new products, QMS, Quality systems and sourcing of new vendors. An autonomous worker committed to providing high quality services. Proficient in New product development, MR ISO 9001:2015, Supplier quality and CAPA preparation.

Overview

6
6
years of professional experience
4
4
years of post-secondary education

Work History

Verification and Validation Engineer

HCL Technologies Ltd
Chennai
01.2021 - Current
  • Test Method Validation (TMV)
  • Design of Experiments (DOE)
  • Generated validation plans for MDR submission projects, setting specific temporal and budgetary goals for development and delivery.
  • Functional verification testing
  • Equipment validation (IQ, OQ & PQ)
  • DHF Remediation and Gap Assessment
  • Produced and maintained technical documentation for project reference (Design Verification & Validation plan, Summary report, Protocol and Special Report etc...).
  • Expertise in Protocol preparation, Test execution planning & Co-ordination and Final report data analyzing.
  • Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
  • Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Developed validation master plans, process flow diagrams and standard operating procedures.

NPD, QA and Vendor Development Engineer

Nordic (India) Solutions Pvt. Ltd and eSV Connect
Chennai
05.2017 - 01.2021
  • BOM & Costing Preparation
  • Prototype making, Material planning, PPAP & APQP documentation
  • MR – QMS ISO 9001:2015
  • IQA, IPQC & OQA & BIS Lab In-Charge
  • Material cost reduction
  • Devised new products and features to boost customer satisfaction, reduce costs and propel product line to industry forefront.
  • Directed, guided and monitored support engineers and in-house operational personnel.
  • Created designs at minimal costs using high-volume manufacturing processes and careful material selection.
  • Communicated with vendors and key suppliers to select project materials and meet customer needs.
  • Drafted clear technical documentation, detailing product design specifications.
  • Collaborated with design team to identify and manage project deliverables for customer orders.

Education

Bachelor of Science - Mechanical Engineering

St. Peter's University
Chennai, India
06.2011 - 05.2015

Skills

Test method Validation (TMV) and Design of Experiments (DOE)

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Additional Information

  • Professional in MS Office tools
  • SME for Accelerated Aging and Environmental Chamber Handling
  • SPOC for Lab activities
  • Technically strong in Jigs and Fixture design
  • Awarded as 2022 best employee for handling challenging deliverables

Timeline

Verification and Validation Engineer

HCL Technologies Ltd
01.2021 - Current

NPD, QA and Vendor Development Engineer

Nordic (India) Solutions Pvt. Ltd and eSV Connect
05.2017 - 01.2021

Bachelor of Science - Mechanical Engineering

St. Peter's University
06.2011 - 05.2015

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KUMARAGURU EVerification And Validation Engineer