Participation in all stages of the E&E projects, starting in the pre-quotation support to the clients, quotation stage, project attendance and payment milestones supervision.
Support and advisory on the business strategy concerning E&E, with the other management positions.
- Since 2019 - Product responsible at CERE
- 2015 - 2019 - Advisor for Medical Device Certification with SGS and AEMPS
- 2008 - 2015 - Quality Manager in several Medical Device Companies
- Latest - Ph.D. degree in Biomedical Engineering
- Previous - MSc. degree in Biomedical Engineering
- Previous - University degree in Electronic Engineer
- Internal and External audits
- Develop and maintain Quality Management System in accordance with medical device regulatory requirements UNE-EN ISO 13485, ISO 9001 standard, product safety compliance and Directive 93/42/ECC to obtain CE Mark
- Complete periodic line checks to determine compliance with product and customer specifications
- Project develop experience (Anaesthesia monitor, pain monitor): Part of the team to research, design and development algorithms for structural pattern recognition on EEG signal processing
- Software design and development for biomedical signal acquisition, processing and analysis (Heart rate Variability, EEG and AEP), in the framework of his doctoral thesis. Project: Characterization of Heart Rate Variability by Hidden Markov Models
- Planning and development of the CICYT projects for biomedical R&D activities of the Ministry of Education of Spain
- Researcher in the CICYT project (TEC2004-02274), Treatment and interpretation of biomedical signals for the clinical evaluation and the rehabilitation. Ministry of Education of Spain
- Researcher in the CICYT project (TIC2001-2167-C02-01), Advanced technologies of treatment of biomedical signals for the monitoring, diagnosis and therapy of pathologies cardio-respiratory. Ministry of Education of Spain
- University Ph.D. degree in Biomedical Engineering at Technical University of Catalonia, Spain
- University MSc. degree in Biomedical Engineering at Autónoma Metropolitana University, Mexico
- University degree in Electronic Engineer at Antonio Nariño University. Accredited title 2005/H01825 to Spanish Electronic Engineering title
Nowadays, and for the last semester, Manuel has been working in CERE as Expert of the testing laboratory in terms of safety for E&E regulatory compliance. Previously and before joining CERE, he was working for a period of more than 3 years in the Medical Device Certification area with Notified Bodies as SGS and AEMPS, Agencia Española de Medicamentos y Productos Sanitarios, assessing whether manufacturers and their Medical Devices meet the requirements set out in legislation according to directives 93/42/ECC and ISO 13485 standard.
During this period working with Notified Bodies, his main functions works as Lead Auditor, Expert and/or Product Assessor on Active Medical Devices in the audit teams, assessing the essential requirements and full quality assurance which the product must meet in the interest of patient safety; allowing manufacturers to put CE-marks on their products and put them on the market in the EU. Currently, he is a member of technical expert group of the AEMPS.
Before Notified Bodies, in his professional career, worked for a period of 7 years as Quality Manager in medical device companies in Barcelona supervising all regulatory compliance activities and helping to enforce quality assurance policies and best practice principals covering the safety, design, production and inspection.
The functions as Quality Manager involved various duties including:
Before these jobs, he worked as a researcher in software and OEM hardware developer R&D novel projects in the Medical Device industry and also during his PhD. studies such as