Description
Luis is a Degreed, MSEE, experienced Project/Engineering Manager. He has hands-on in R&D, Production and Quality with 30+ years' experience in Medical Devices providing an energetic, creative thinker that strives to continuously improve the Quality of Products. * Experienced in Quality Systems, DFM, DFT, Design Controls. Completed R&D of semiconductor CMOS transducers and sensors: temperature, pressure, optical, x-ray scanners for medical and security. Designed and built the first prototype of the X-ray scanners for security used in airports all over the world. * As part of the development and design process I did gather user needs to include them as design inputs, and as well as system requirements, I performed these functions in several of my jobs. * Designed and built the first Oxygen Conserver "Oxymatic" in the world selling since 1986. Developed drug delivery devices, insulin and oxygen. Spent a number of years in R&D of Respiratory Devices: Conservers, ventilators, CPAP. * Coordinated and manage calibration and maintenance of production, test and laboratory equipment. * Managed and led teams, performing system design, circuit design, Root Cause Analysis, CAPA, Manufacturing, Supplier auditing, and performed Validation & Verification on the electronic applications in Class II/Class III implantable and external devices. * Managed functions in the R&D Department, completed validation protocols of present and new products and devices, including software. Performed remedial tooling Validation and internal CAPAs to help with the resolution of present and past issues that caused a warning letter from FDA. Personally trained and developed many staff and technical personnel through the years. * Specified state of the art high tech components that comply with REACH and Directive 2011/65/EU Restriction on Hazardous Substances (RoHS). * Completed a Six Sigma Green Belt class. * Management covering also MRB, CCB, DFMEA, PFMEA ( IQ, OQ, PQ), Design History File (DHF), Technical File, Design Dossier Documentation for FDA reporting for Finished Medical Device Products. CFR21 Part 820 QSR and Parts 210 & 211 cGMPs and ISO 9001, ISO 14971, IEC 62366 and ISO 13485 regulations IPC 600, IPC-A-610, IEC-60601, SP10, GD&T Y14.5-2009 among other standards. Worked to meet requirements from UL, CSA NRTL and more. Managed vendors molding plastic parts, machined parts and other mechanical parts, along with motors: AC, DC and stepper. Flex and rigid PCB circuits, design, manufacturing, supplier management. * Performed testing for compliance and V&V at Nemco (ESD, EMC/EMI) and other labs. Knowledge of mechanical inspection methods. Smart Scope Trained. * Wrote user SOPs, Manufacturing Instructions, Technical Manuals. Performed functions on Marketing and sales support. Improved reliability department and had approval signature on all their test reports. Performed Systems Engineering. * Managed and coached multidisciplinary teams and projects.
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