I am a Biomedical Eng with 5 years of experience in medical device development
I've worked in product development, quality assurance, and system engineering positions for development of Class II medical devices for Latin America, Europe and US markets. I have experience with implantable and... More
Support Process Eng. Manager and team in manufacturing process design, implementation and maintenance.
Lead projects for design and development of Class II medical devices, for EU and LATAM markets. I was part of men's health solutions team, leading erectile dysfunction division.
HW Development of IVD devices. Lead activities related to the integration molecular biology assays into medical devices, ensuring compliance with FDA regulation.
System development of IVD devices, leading activities of system definition, verification, validation, documentation and compliance with applicable regulation.
Biomedical Engineering Degree (5.5 years) [MSc. equivalent] Final Degree Project: "Functional characterization of an implant components for urinary incontinence treatment, using finite elements method - In vivo study".
Granted Scholarship for one semester abroad in Spain, Basque Country. LAMENITEC - ERASMUS MUNDUS (Basque Country - Mondragón). Final Project: "Analysis of technological solutions for osteoarthritis treatment"
Master in Business Administration (MBA) not completed Key approved subjects: - Marketing Management - Business Administration and Organization - Financial Accounting
Postgraduate Degree - Management in Medical Devices Design and Development - IN PROGRESS
Common risk-management methods used in product design of medical devices and manufacturing processes
Test Method Validation course by AAMI society
Regulatory Affairs Certificate: Medical Devices from RAPS society
Internal Auditor ISO 13485:2016 certification
I love to read books from different topics like personal development, economy, regulatory affairs, or project management. I'm also an active person who work out, and enjoy outside walks and some running on weekends.
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