Tamizharasan Rajaraman

About Tamizharasan Rajaraman

Research & Development Engineer with 9+ years career experience on providing cost effective solutions. Experienced in System Engineering, Product Relaunch, DHF Remediation and Design Verification and Validation, Sustenance Engineering, PLM/PDM for high regulated domains like medical device development and automotive industries.•Experienced in V-model, Waterfall and Agile approaches and decomposing the Essential requirement standards and gathering product, element and part requirements. •Expert in creation of Eco Design product deliverables like Eco Passport, Recycling Passport, Product sustainability data, Hazardous substances management Report, Product sustainability risk matrix and dispensation forms by considering Substances, Energy, Packaging, circularity and weight as a part of Product sustainability. Good understanding in upcoming CSRD Regulation.•Expertise in qualifying changes (design/material) to disposable Medical devices per ISO 13485/ US FDA 21 CFR Part 820 QSR Requirements.•Experienced in supporting R&D & Quality functions for 510(k) Submissions to FDA, MDR/MDD (Notified body) and conducting Formal Technical Reviews.•Preparation of Technical Documentation, Declaration of Conformity and Design Traceability matrix for MDR/MDD Submissions of Class I & Class II Medical devices.•Experienced in remediation activities like DHF, Tech file remediation and performing gap assessment to fulfill MDR 2017/745/MDD regulatory standard requirements.•Experienced in Design control procedures (21 CFR 820.30), Medical Device Design Standard (IEC 60601 series, ISO 17664-1, ISO 15223, ISO 20417, ISTA Series, ISO 18562, ISO 10993, ISO 9626, ISO 23908, ISO 594 / ISO 80369 and ISO 11607 etc.) remediation to current release / suspended standard.•Experienced in Performing Functional Stability and shelf-life test’s (Accelerated and Real-time) for Medical devices and preparing Memo, Protocol, Stability Reports (Design Verification & Validation), Design Output Documents (Product spec, Material BOM etc).•Good at Statistical software (Minitab) for obtaining results for design verification and validation.•Proficient in leading Design Verification, Validation activities & Labeling Product line Support (PLS) Projects and hands on experience on GDP and GMP.•Experienced in Sample selection to perform the shelf life testing based on required confidence and reliability as per risk management references.•Risk management ISO 14971.•Experienced in handling NC, CAPA, Complaint investigation and supporting MDSAP & TUV audits with evidences.

Experience

1. Professional Ii - Mechanical & Physical Engineer

   Capgemini Engineering

   Aug 2022 — Present · Bengaluru, IN

Education

• DHANALAKSHMI SRINIVASAN ENGINEERING COLLEGE

  Bachelor of Engineering (B.E.)

  2011 — 2015

Skills

• Catia
• Creo 2.0
• Cosmos Fea
• Nx Unigraphics
• Autocad
• Solidworks
• Ansys