Hareesh S

Hareesh S

Graduate Trainee

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location of Hareesh SBengaluru, Karnataka, India

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  • Timeline

  • About me

    Project Lead - Medical Devices - EU MDR - Regulatory Affairs - Compliance Handling- Remediation Projects - DHF - Post Market Surveillance - Product Lifecycle Management - Medical Devices Regulatory Information (RIM)

  • Education

    • SRK MATRICULATION HIGHER SECONDARY SCHOOL

      2011 - 2013
      HSC Computer Science

      Maths ,Physics,Chemistry

    • St JOHN'S MATRICULATION HIGHER SECONDARY SCHOOL

      2001 - 2011
      SSLC
    • KSR INSTITUTE FOR ENGINEERING AND TECHNOLOGY, NAMAKKAL

      2013 - 2017
      B.E. Mechanical Engineering
  • Experience

    • Brakes India Private Limited

      Jul 2017 - Dec 2017
      Graduate Trainee
    • HCL Technologies

      Feb 2018 - Feb 2022
      Project Lead

      Working as a CAD Engineer, Performed CCM (Change Control Management), DMR & DHF File Indexing, BOM Structure Creation, Specification Standardization, Design History File Remediation and Design Verification & validation, Value Analysis and Test Method Validation and Value Engineering. Job Responsibilities and Accomplishments● Design Parameter Activity: Executing assigned work requests pertaining to creation of drawings, models and low level designs through various tools like Creo, Catia V5, Ansys, Fluent etc. as per the client requirements within stipulated timelines. To create new designs and models or redo the existing model for meeting client’s prescribed standards for New Product Development (NPD).● Working on BOM structuring, Design Parameter Input analysis, manually review and validate the generated outputs; maintain relevant documentation in client database.● Team Center Unified Migration: Migrating DHF, DMR files from customer’s drive to Team Center Unified using scripts. High level knowledge and experience on TcU (Team Center Unified): My Team Centre, Structural Management, Workflow designer, etc.● DHF Remediation: Remediate the DHF files like plan document, Labelling documents, system and sub system documents, FMEA documents, etc.● CCM: Experience with Engineering Change Control (ECN/ECO Process) using Track Wise Tool.Responsibility of the Internal Quality Audit (IQA) and Various Project Management tools.● Test Method Validation: Performed Test Method Validation (variable study) on inspection equipment’s (Video Measuring System) with Gauge R&R using Minitab 16, DFA/FMEA on NPDs.● Quality Activity: Six Sigma Green Belt Holder, Responsibility of the Internal Quality Audit (IQA). Show less

    • Freyr Solutions

      Feb 2022 - Apr 2023
      Senior Associate
    • Tata Consultancy Services

      Apr 2023 - now
      IT Analyst

      Prepare and update post market surveillance plan (PMSP), related activities & post market surveillance report (PMSR / PSUR) for medical devices (combination products).Assessment of public reporting health authority safety databases for post-market surveillance. Coordinate the PMS data quarterly reviews and document the meeting minutes.Communicate the quarterly review recommendations to Management Representatives during Management Review.Collect, analyses and present data using appropriate visualization tool (e.g. Tableau, Power BI and Qlik Sense) to support report preparation. Show less

  • Licenses & Certifications

    • Digtal Marketing

      Google
      Feb 2019
    • Communicating with Executives

      LinkedIn
      Dec 2023
    • Six Sigma Green Belt (CSSGB)

      TUV India Pvt. Ltd.
      Dec 2023