
Hareesh S
Graduate Trainee

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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 - 2013HSC Computer ScienceMaths ,Physics,Chemistry

St JOHN'S MATRICULATION HIGHER SECONDARY SCHOOL
2001 - 2011SSLC
KSR INSTITUTE FOR ENGINEERING AND TECHNOLOGY, NAMAKKAL
2013 - 2017B.E. Mechanical Engineering
Experience

Brakes India Private Limited
Jul 2017 - Dec 2017Graduate Trainee
HCL Technologies
Feb 2018 - Feb 2022Project LeadWorking 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 2023Senior Associate
Tata Consultancy Services
Apr 2023 - nowIT AnalystPrepare 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
GoogleFeb 2019
Communicating with Executives
LinkedInDec 2023
Six Sigma Green Belt (CSSGB)
TUV India Pvt. Ltd.Dec 2023
Languages
- enEnglish
- frFrench
- taTamil
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