KATHIRAVAN.

R
kathiravanrajarajan@gmail.com | B.E Mechanical Engineering |+91 88386 51514 | Chennai, Tamil Nadu |Total Exp: 5+ years
Medical Device – Product Development, ISO:14971 Risk Management, ISO:13485 QMS

OBJECTIVE
Energetic Engineer seeking an opportunity to merge my initiative and enthusiasm with 5 + Years of proficiency to add value both to
the organization and to myself. To aim at expanding my horizons and develop skills in the field of “Medical Devices - Design Controls,
Risk & Requirement Management and Quality Management System” and work in a dynamic environment that provides
opportunities for my growth.

AREAS OF INTEREST
 Medical Device – Design Quality Assurance  Hazard Analysis, FMEA, FTA
 ISO 13485 Quality Management System  Post Market Surveillance – Complaints Handling, CAPA
 ISO 14971 Risk Management  Project Management
 21 CFR Part 803, 820, 822, 860  EU MDR 2017/ 745

TECHNICAL SKILLS
 PLM: Windchill
 Risk Analysis: FMEA (MED 7/8), FTA, Hazard Analysis
 Statistical Analysis: Minitab

PROFESSIONAL & INDUSTRIAL EXPERIENCE

1. HCL Technologies Ltd (Current Company) Feb 2019 to Till Date

Designation: Lead Engineer in Engineering and R&D services

Roles & Responsibilities:
▪ Perform Medical Device Risk Analysis: Hazard Analysis, FMEAs & Fault Tree Analysis associated with the Product and prepare
mitigation plan for medical devices aligning to ISO: 14971 & 13485
▪ Investigate the complaints using the GCMS-Track Wise tool and assess the Risk Index of Pelvic organ prolapse (POP) surgical
meshes
▪ Retro & Prospective complaints to report with FDA through e-MDR Submission right from Investigation to Closure phase.
▪ Recalibrate the Risk Indices for Pelvic organ prolapses (POP) surgical mesh products by updating Hazard Analysis, Design FMEA,
Use FMEA, Harms Trace Matrix, Risk Management Plan and Report
▪ Compile Usability Engineering Summary Report and subset of activities (like Usability Plan & Report) for Legacy products to
show evidence that commercialized products are conforming to IEC 62366-1:2015
▪ Compile MRA (Master Risk Assessment) document for endoscopic clipping device
▪ Prepare Occurrence calculation sheet as supporting document for Master Risk Assessment from PMS Data
▪ Analyze and Investigate Post Market Surveillance Data for the root cause or major driver identification and track the
complaints through CAPA
▪ Knowledge in Urology, Pelvic Health, Endoscopy, Infusion Pumps, Balloon Ablation Catheter, Hips & Knee joints replacement
Implants and Cochlear Implant product lines.
▪ Hands on experience in Supply Chain Management- creating variants compiling to EU MDR regulation from legacy products of
MDD regulation for business continuity.
▪ Basic knowledge on Windchill PLM Management Cognition Cockpit tool.

Clients Handled:

1
2. RANE Madras Ltd May 2013 to Apr 2014

Designation: Graduate Trainee (Manufacturing Quality Assurance)

“RANE Madras LTD was founded in 1929 and it is a leading manufacturer of Steering and Suspension Systems, Friction materials,
valve train components, occupant safety systems, and Die-casting products and provides connected mobile solutions. Serves a
variety of industry segments: Passenger Vehicles, Commercial Vehicles, Farm Tractors, Two-wheelers, Three wheelers, Railways,
and Stationary Engines.”

Roles & Responsibilities:

▪ Conduct Line Quality Inspection for first-off approval and defect identification.
▪ Initiate CAPA for defect management parts in the manufacturing line.
▪ Exposure to manufacturing line and took part in Process/Product Audits.
▪ Exposure to Kaizen, QC Tools, 8D, Poka Yoke techniques.
▪ Prepare Layout Inspection and new product development Quality approval.
▪ Handle customer complaints to implement CAPA and monitor for effectiveness.
▪ Hands-on experience with various measurement systems – Profile projector, Slip gauges, Contour machine (Surface finish),
Digital micrometer & Vernier Caliper, Height gauge, Universal Testing Machine (Torque Indicator).
▪ Perform Measurement System Analysis (MSA) studies – Gage R&R, SPC.

Achievements:
▪ Successfully faced TS-16949 audit in 2013 at Rane madras Ltd, plant IV.
▪ Fixture Development for assembly check to ensure the right assembly is getting delivered.
▪ Poke Yoke installation in the manufacturing line.
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Clients Handled:

PERSONAL STRENGTH
▪ Positive attitude and Responsive.
▪ Personal and professional ethics fosters a diverse and respectful workplace.
▪ Confident and Team Player.
▪ Commitment towards the work.
▪ Good communication and interpersonal skills.
▪ Quick learner and good at prioritizing and achieving.

I hereby declare that the above details are true to the best of my knowledge and belief.

Date: 04-Nov-2023 Signature

Place: Chennai

(R. Kathiravan)