プロフィール詳細

プロジェクトを作成

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Dr. Paolo S.に依頼

United Kingdom

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

プロフィール概要

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.

専門分野

• ★ 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

サービス

• Writing
• Research
• Data & AI

Writing Technical Writing

Research Systematic Literature Review

Data & AI Statistical Analysis

職務経験

Project Assistant

Pharmi Med Ltd.

1月 2020 - 現在

System Quality Assurance

Elements Technology

10月 2019 - 現在

Independet Consultant / Founder

Máseru SAS

6月 2019 - 現在

Biomechanics Adjunct Professor

Pontificia Universidad Javeriana, Bogotá Colombia

1月 2019 - 7月 2019

Post-doctoral researcher Biomedical Engineering Group

Universidad de los Andes, Bogotá, Colombia

7月 2018 - 7月 2019

学歴

PhD Engineering

Andes University, Bogota, Colombia

8月 2014 - 10月 2018

MSc Biomedical Engineering

TU Delft, The Netherlands

8月 2011 - 11月 2013

Mechanical Engineering

Andes University, Bogota, Colombia

8月 2007 - 7月 2011

認定資格

• 認定資格の詳細は未入力です。