Deep Enrich
Sreejith Sreekumar
Design Engineer
402 followers
London Area, United Kingdom
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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 - 2015Bachelor of Technology (B.Tech.) Mechanical Engineering
Experience
Apollo Tyres Ltd
Jun 2016 - Oct 2017Design EngineerEngineering Drawings | CAD Modelling | P&ID Drawings | Dimensional Inspection | Handling Precision Measuring Instruments | SAP PM module
Terumo Blood and Cell Technologies
Oct 2017 - Jul 2021R&D Engineer - Innovation & DevelopmentDesign & 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 - nowLead EngineerEquipment 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 ProviderMay 2024- View certificate
Internal Audit on Medical Device QMS - ISO 13485: 2016
StendardNov 2025
- View certificate
Lean Six Sigma Foundations
LinkedInOct 2024 - View certificate
Medical Device Process Validation ISO 13485
UdemyMay 2025
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