Summary
Overview
Work History
Education
Skills
Additional Information
Certification
Languages
Timeline
Generic

Mahendran Murugesan

Raynham,USA

Summary

PROFILE SUMMARY: Experienced professional with over 8+ years of experience in medical device domain. Proven track record in delivering remediation and new product design and development projects, as well as technical documentation involving risk management, DHF documentation, product design, concept creation, 3D CAD modeling, detailed design, labeling remediation, and change development. DOMAIN AND CAD SKILLS Qualified Mechanical Engineer with extensive knowledge of engineering equipment and software. Committed to providing accurate work with eye for detail. Consistently commended for meeting stringent project deadlines under budget. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Mechanical Engineer

R&D Spine
  • Performed Tech file planning and scope assessment
  • Provided Project Execution plans based on the Tech file planning and scope assessment
  • Performed gas assessment on risk management documents (RMP, RAC
  • DFMEA, RMR, IOVV)
  • Performed updating of the Risk Management Files for DePuy Spine products in line with the General Safety and Performance Requirements specified within European Union Medical Device Regulations (EU-MDR)
  • Reviewed and analyzed the complaints from PMS report to map to Design
  • FMEA for occurrence rating
  • Reviewed the validity of the technical document reference in the design
  • FMEAs
  • Reviewed Design Inputs and Outputs for MDR compliance
  • Led the execution of all Risk Management process activities
  • Created redlines for the prosed changes of the risk management documents (RMP, RAC, DFMEA, RMR, IOVV)
  • Reviewed First Article Inspection (FAI) and tolerance analysis retrospectively
  • Co-ordinated with a cross-functional project team for design review from
  • Regulatory, Medical, R&D, Restricted Substances, Biocompatibility, Post-
  • Market Surveillance, and any other functions as needed
  • Managed Change management process for the documents for approval
  • Tools MS Office & MS Excel
  • Planned [Number] [Type] projects from beginning to end, focusing on timelines, budgets and mechanical feasibility

Quality Engineer

Mahendran Murugesan
  • 240-0177 mahendronz@gmail.com
  • Review of existing technical file with requirements of technical documentation
  • Identified applicable standards for product based on local country regulation
  • Assessing difference in latest and previous edition of IEC standards
  • Gap assessment of harmonized standards for MDR compliance like
  • IEC60601, EN 62366-1, EN ISO 15223-1, EN ISO 16061, ISO 10993-1
  • Verified product and documentation meets IEC standards (IEC 60601- IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 62133-2) and identified any gaps
  • Prepare Gap assessment Summary sheet of device classification, General safety and permanence requirement, technical documentation, Clinical
  • Evaluation and Post-Market Clinical Follow-Up
  • Updating Risk management documents to meet MDR requirements (Plan and FMEA, RMR)
  • Post market surveillance activities
  • Internal complaints and CAPA search
  • External Complaints, recalls search
  • Tools MS Word, MS Excel
  • Quality Support for Spinal products, Prepared pilot and validation report, as well as BOMs, component drawings and manufacturing procedures
  • New Product Introduction (NPI) and authoring/execution of validation protocols
  • Created and maintained Drawings, BOMS and Documents for the existing and new products
  • Test Method Validation documents preparation such as requirement analysis
  • First Article Inspection (FAI), Installation Qualification (IQ), Operational
  • Qualification (OQ), Process Qualification (OQ), Component Requirement
  • Review (CRR), Gage Repeatability and Reproducibility (GR&R), Incoming inspection
  • Prepared PPAP documentation for part approval
  • Improved product and process design by writing engineering change notifications (CR, CN)
  • Analyzed and improved test methods through screening experiments and released TMVs & Gage R&Rs

Design Engineer

Mahendran Murugesan
  • 240-0177 mahendronz@gmail.com
  • Worked on Incoming Inspection sheet for design change
  • Knowledgeable/Experience in, Design of experiment, Lean Manufacturing, 6 sigma, 5S, Gage R&R, DMI/DFA, PFMEA, CAPA, Capability study, Process flow diagrams, root cause analysis, value stream mapping
  • Supported daily manufacturing and daily operations to meet customer requirements
  • Environmental compliance check activities that include
  • Identifying RoHS directive and submission process for local country regulation
  • Verifying the product’s environmental compliance for RoHS, REACH
  • Project
  • Name
  • Design and development of Automated Cap Feeding system for test tubes
  • Description
  • Objective is to develop a system that intend to feed the test tube caps to robotic arm in specific orientation
  • Role&, Understand the functionalities, requirements, and issues of the existing feeding system in the market
  • Carried out voice of the customer (VOC) based on that user needs are clearly defined
  • Actively participated in brainstorming session to generate ideas based on the VOC / Market Requirement
  • Concept creation for orienting and feeding caps
  • Responsible for the development of the proof of concept, CAD models and mechanism for the better understanding of the concepts Identification and selection of the vendors for Prototype activity
  • Generation of 3D CAD Models and detailed drawings and quality check as per design standards
  • Tolerance Stack up analysis is done to ensure the design intent is met & updated the drawings based on the analysis
  • Review assemblies and parts to identify scope for Cost Reduction
  • Performed design stage reviews with cross functional team during each stage of product development process (PDP)
  • Actively participated in DFMEA reviews with cross functional teams
  • Tools Solid works 2016

Depuy Synthes, Johnson & Johnson, S2SSoft, LLC
08.2021 - Current
  • R&D Spine MDR – Life cycle, Providing R&D Engineering support for Risk management remediation for quality and MDR compliance

Regulatory labeling Analyst

Ethicon, Johnson & Johnson, L&T Technology Services
01.2020 - 07.2021
  • EU MDR – Life cycle projects Duration, Description
  • Objective is to evaluate the existing labeling components content (Packaging labels and IFU) and perform gap analysis and labeling development and remediation activities for MDR compliance
  • Role&, Led labeling artwork projects for changes to existing product labeling components (Instructions for use, Tyvek, sales cartons, shipper label etc.)
  • Assess and analyze the content of labeling components to ensure compliance with regulatory requirements and company guidelines (MDR and FDA)
  • Performed redlines for Packaging components (foils, carton and sleeve)
  • Collaborated and facilitated review and approval processes with appropriate cross functional teams (such as Regulatory Affairs, Quality, Manufacturing
  • Graphics, Legal, Quality, Supply Chain, Marketing, R&D, Engineering)
  • Executed and managed multiple projects simultaneously to meet the MDR submission
  • Coordination with packaging / graphic designer for label and packaging drawing updates
  • Documented detailed description of changes to provide traceability from documents and reports to labeling elements
  • Managed Change management process for all the documents for approval
  • Tools MS Office & MS Excel

L&T Technology Services
10.2014 - 12.2019
  • EU MDR Gap Assessment and Remediation of technical documentation
  • Description
  • Objective is to assess and identify the gap and its remediation GSPR and Technical documentation for Knee, hip, shoulder and ankle implants to ensure compliance to
  • New EU Medical Device regulations
  • Role&
  • Contribution
  • Responsibilities:
  • Understanding of MDR requirements of labeling, GSPR and Technical documentation for Class I, IR, IIb and III device
  • Assess Product classification as per new rules
  • Review of existing “Essential Requirements” with respect to General Safety & performance Requirements.

Education

Bachelor of Science - Mechanical Engineering

PSG College of Technology
Coimbatore, Tamil Nadu
04.2014

Skills

  • Domain Medical Devices
  • PLM Tool ADAPTIV, Windchill
  • 3D CAD Tools Solid works, Creo 30
  • Other tools MS Word, MS Excel, Adobe Acrobat DC
  • Project Management
  • Tools
  • Jira, SharePoint
  • Root Cause Identification
  • Quality Assurance
  • Change Management
  • Multitasking and Organization
  • Risk Management
  • FMEA Certification

Additional Information

  • Strong understanding of medical device regulations and standards, including EU MDR 2017/745, 21 CFR 820, ISO 13485, IEC60601 and ISO 14971. Experienced in EU MDR Gap assessment for harmonized standards and Regulatory Technical documentation. Experienced in New Product Design & Development, Reverse Engineering, remediation, and substance projects involving in 3D model Migration activities involving the modelling of Plastic and Die Casting Components, Sheet Metal, etc. Extensive experience in Risk Management activities for Class I, IIa, IIb, and III devices. Experienced in complaints analysis, Maude search, PMS report complaints review and mapping. Hand on experience in Geometric Dimensioning and Tolerancing (GD&T) Worked on MDR medical labelling projects including gap assessment and redlining. Experience in Process validation such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and Test Method Validation, First Article Inspection (FAI), Gage Repeatability and Reproducibility (GR&R), Capability study Proven ability to lead and manage various remediation projects. Experienced in working with cross-functional teams in multiple projects. Proven ability to coordinate with various cross-functional SMEs for input collection, gap identification, review, approval, and implementation. Ability to lead and coordinate with offshore team.

Certification

Certified on SOLIDWORKS Professional-Mechanical design (CSWP: ID: C-S6EKRY7LKK)
Certified on Lean Six Sigma Methodology (Yellow Belt)

Languages

English
Full Professional
Tamil
Native or Bilingual

Timeline

Depuy Synthes, Johnson & Johnson, S2SSoft, LLC
08.2021 - Current

Regulatory labeling Analyst

Ethicon, Johnson & Johnson, L&T Technology Services
01.2020 - 07.2021

L&T Technology Services
10.2014 - 12.2019

Mechanical Engineer

R&D Spine

Quality Engineer

Mahendran Murugesan

Design Engineer

Mahendran Murugesan

Bachelor of Science - Mechanical Engineering

PSG College of Technology

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