James Freitas Email & Phone Number

Principal Engineering Contractor, JAMES FREITAS ENGINEERING CONSULTING, LLCPrincipal Engineer, ST. JUDE MEDICAL Director of Manufacturing, CEREBROTECH MEDICAL SYSTEMSDirector of Operations, VENITI, INC.Manager, Manufacturing Engineering, NEOTRACT, INC.Senior R&D Engineer, NEOTRACT, INC.Senior Manufacturing Engineer, THORATEC CORPORATIONSenior Staff Engineer, MEDTRONIC NEUROSURGERYPlant Operations Manager, ATS PRODUCTS, INC.Industrial Engineer, ATS PRODUCTS, INCStrategic partner within the Preferred Regulatory Consulting network: https://preferredregulatoryconsulting.com/Development.htmlDependable and seasoned engineering professional with over 25 years of progressive engineering and management experience from within the medical device and semiconductor industries. A hands-on, motivated, and results oriented creative thinker with a proven track record of effective leadership in early-stage development, process engineering, and manufacturing management. Dynamic experience dedicated to the development of class II and class III implantable and non-implantable gastrointestinal, dermatologic, venous, urological, cardiovascular, thrombectomy, otorhinolaryngological, and neurological medical devices. Recently an essential part of talented team on a mission to develop an innovative neurological monitor for detecting early stages of cerebral edema and bleeding in patients after a stroke or brain trauma. There is a significant and unmet clinical need for a non-invasive continuous monitoring system for detecting small changes in brain fluids to enable earlier intervention. Prior, James was a chief contributor for startup company pioneering advanced technologies strategically focused on the management and comprehensive treatment of chronic venous insufficiency, a condition that affects up to 20% of all U.S. adults. As another proceeding accomplishment, James was an integral team member of an early-stage startup company supporting efforts developing a minimally invasive therapy and novel FDA DeNovo approved device used to treat benign prostatic hyperplasia (BPH). Throughout his successful profession, James has also played considerable roles in endeavors acquiring CE Mark and FDA approvals for cardiac ventricular assist systems used to treat congestive heart failure patients, as well as hydrocephalus shunt systems, neurosurgery endoscopes, critical care drainage systems, and cranial closure devices used in neurosurgical procedures.

Listed skills include Medical Devices, Manufacturing, Design Control, Fda, and 13 others.

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  San Francisco State University

  Industrial Technology