Sreejith Sreekumar

London Area, United Kingdom

402 followers

Timeline
About me
R&D Engineer | Medical Devices | ISO 13485 | EU MDR QMS | US FDA 21 CFR 820 QSR | Product Development | Design Verification & Validation | Process Validation | Risk Management
Education
- Vkcet
  2011 - 2015
  Bachelor of technology (b.tech.) mechanical engineering
Experience
- Apollo tyres ltd
  Jun 2016 - Oct 2017
  Design engineer
  Engineering Drawings | CAD Modelling | P&ID Drawings | Dimensional Inspection | Handling Precision Measuring Instruments | SAP PM module
- Terumo blood and cell technologies
  Oct 2017 - Jul 2021
  R&d engineer - innovation & development
  Design & Development | Process Validation, Equipment Qualification, IQ OQ PQ | Design Verification & Validation | Minitab | Test Method Development | Test Method Validation
- Hcltech – engineering and r&d services
  Jul 2021 - now
  Lead engineer
  Equipment Validation| Process validation | Facility Qualification | Design Verification & Validation |Risk Management ISO 14971 | FMEA | ISO 13485 QMS | 21 CFR 820 | ISO 17665
Licenses & Certifications
- Developing business acumen
  Pmi® registered education provider
  May 2024
- Internal audit on medical device qms - iso 13485: 2016
  Stendard
  Nov 2025
  View certificate
- Lean six sigma foundations
  Linkedin
  Oct 2024
  View certificate
- Medical device process validation iso 13485
  Udemy
  May 2025
  View certificate