Profile Details

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Hire Dr. Paolo S.

United Kingdom

USD 50 /hr

Medical Devices R&D | Validation and Verification following Q/RA | Computational simulation applied to MD

Profile Summary

Doctor in Engineering specialised in medical devices research and development. Focused on validation and verification of development processes following quality and regulatory standards. Experience on the application of computational simulation techniques for device design, development and testing. Competent in software development, using mainly Python. Certified Auditor leader on ISO 13485:2016 the worldwide used standard for the definition of the required Quality Management System (“QMS”) for the design and manufacture of Medical Devices.

Subject Matter Expertise

• ★ Data Analysis
• ★ Computer Simulation/Computational Modeling
• ★ Medical Devices
• ☆ Biomaterials
• ☆ Mechanical Engineering
• ☆ Fluid Mechanics
• ☆ Data Science
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Cardiovascular Disease
• ☆ Experimental Protocols

Services

• Writing
• Research
• Data & AI

Writing Technical Writing

Research Systematic Literature Review

Data & AI Statistical Analysis

Work Experience

Project Assistant

Pharmi Med Ltd.

January 2020 - Present

System Quality Assurance

Elements Technology

October 2019 - Present

Independet Consultant / Founder

Máseru SAS

June 2019 - Present

Biomechanics Adjunct Professor

Pontificia Universidad Javeriana, Bogotá Colombia

January 2019 - July 2019

Post-doctoral researcher Biomedical Engineering Group

Universidad de los Andes, Bogotá, Colombia

July 2018 - July 2019

Education

PhD Engineering

Andes University, Bogota, Colombia

August 2014 - October 2018

MSc Biomedical Engineering

TU Delft, The Netherlands

August 2011 - November 2013

Mechanical Engineering

Andes University, Bogota, Colombia

August 2007 - July 2011

Certifications

• Certification details not provided.