Mechanical engineer with MBA in Project Management and 10+ years experience on the design of medical devices (anesthesia machines, lung ventilators, breathing systems and oxygen therapy products). Experience in project management applying PMBOK and design controls practices for medical devices manufacturers. Used to lead multidisciplinary teams, including mechanical, electronics, software and process engineers. Leader in the implementation of risk management, usability engineer, verification, validation and other medical device processes in the development life-cycle. Expertise in medical device standards as ISO 14971, ISO 13485, IEC 60601-1 series, IEC 62304, IEC 62366 and others. Practical experience on the INMETRO, CE and FDA certification process. Good communication skills. Availability to travel.
Listed skills include Medical Devices, R&D, Engineering, Fmea, and 17 others.