Michael Valencia Email & Phone Number

United States

United States

San Diego Metropolitan Area

Research Engineer, Camino and EDS product portfolios

Salt Lake City Metropolitan Area

 Engaged with product line reverse engineering, remediation, and duplication regarding the Natus Neuro EDS and Camino product lines. Developed project timeline projection, validation master plans, risk assessments, root cause analysis, Internal CAPAs, D/P FMEAs, with regards to new product line transfer and manufacturing processes. Performed various material and process testing for equipment/fixture reverse engineering, product development, TMVs, Gauge R&R, and Manufacturing process… Show more  Engaged with product line reverse engineering, remediation, and duplication regarding the Natus Neuro EDS and Camino product lines. Developed project timeline projection, validation master plans, risk assessments, root cause analysis, Internal CAPAs, D/P FMEAs, with regards to new product line transfer and manufacturing processes. Performed various material and process testing for equipment/fixture reverse engineering, product development, TMVs, Gauge R&R, and Manufacturing process improvement. Defined, designed and conducted various testing, ensuring 3rd party supplier raw material products meet specification requirements, while identifying opportunities for test development and product improvements.  Liaison with various equipment, test fixturing manufacturers and suppliers to ensure proper material quality, equipment specifications, and manufacturing procedure implementations are met.  Senior Engineer tasked with reverse engineering and improvement upon outdated electrical and mechanical manufacturing equipment.  Demonstrated ability to take an analytical approach to problems and work well within in a team environment. Show less

Salt Lake City Metropolitan Area

 Developed working knowledge of EU MDR and MDD regulations as well with ISO standards; ISO 13485, ISO 14971 and FDA 21 CFR 820 requirements. Lead and participated in risk assessment, root cause analysis, and D/P FMEAs for various projects. Managed relevant material testing for product development by establishing and maintaining good test lab practices and procedures. Defined, designed and conducted various testing, ensuring products meet requirements while identifying… Show more  Developed working knowledge of EU MDR and MDD regulations as well with ISO standards; ISO 13485, ISO 14971 and FDA 21 CFR 820 requirements. Lead and participated in risk assessment, root cause analysis, and D/P FMEAs for various projects. Managed relevant material testing for product development by establishing and maintaining good test lab practices and procedures. Defined, designed and conducted various testing, ensuring products meet requirements while identifying opportunities for testing and product improvements.  Liaison with manufacturers and suppliers to ensure proper product quality and process performance.  Launched Securis securement dressing device under MDD regulations into the European markets with CE labeling. Created and submitted multiple IDRs, drawings, and documentation for new product design implementations in current medical devices.  Designed custom tooling and test fixturing in CAD software required for product testing. Worked in the EU MDR remediation project for the StatLock product portfolio as part of the STED submission team and product testing.  Demonstrated ability to take an analytical approach to problems and work well within in a team environment. Show less

Greater Salt Lake City Area

 Team leader for product design and development of a Esophageal Dilator with innovative applied drug delivery. Developed device prototype design and established device prototype testing plan for verification and validation. Applied creative thinking and engineering principles in problem solving to design, model and prototype a new schematic for a syringe and drug delivery device, to be compliant with a FDA PMN/501(k) submission.  Coordinated project team members by assigning and… Show more  Team leader for product design and development of a Esophageal Dilator with innovative applied drug delivery. Developed device prototype design and established device prototype testing plan for verification and validation. Applied creative thinking and engineering principles in problem solving to design, model and prototype a new schematic for a syringe and drug delivery device, to be compliant with a FDA PMN/501(k) submission.  Coordinated project team members by assigning and managing responsibilities through project reviews and meetings in order to meet project goals and retain project timeline. Worked closely with a clinician and presented findings to professors and peers under a professional setting. Prepared all proper documentation for filling of a provisional patent in the US. Show less

Greater Salt Lake City Area

 Developed model of rodent brains with University of Utah FEBio software to analyze brain plasticity properties. Researched, studied and determined areas of interest in rodent brain susceptible to blast trauma for modeling and testing bTBI in mice. Independently developed a computer program that will autonomously determine cell count and cell density in images to minimize human bias/error for differentiating severities of bTBI within mice. Applied program and analyzed imaging… Show more  Developed model of rodent brains with University of Utah FEBio software to analyze brain plasticity properties. Researched, studied and determined areas of interest in rodent brain susceptible to blast trauma for modeling and testing bTBI in mice. Independently developed a computer program that will autonomously determine cell count and cell density in images to minimize human bias/error for differentiating severities of bTBI within mice. Applied program and analyzed imaging data in order to confirm selected areas of the brain feeble to bTBI. Program design and development was self-driven to aid in gathering standardized non bias data for publication. Assisted in the writing and editing of a research entry prior to publication. Show less

Greater Salt Lake City Area

 Investigated MRI sequencing and applied critical thinking to develop a program for Tractography of Neural Tracts within the heart using computational programing. Troubleshooted and evaluated the irregular directionality of neural tracts to accurately model propagation of stimuli in the heart. Created a GUI and have the user select where the stimulus originates within the heart allowing a visual representation for stimulus traveling through the neural structure of the… Show more  Investigated MRI sequencing and applied critical thinking to develop a program for Tractography of Neural Tracts within the heart using computational programing. Troubleshooted and evaluated the irregular directionality of neural tracts to accurately model propagation of stimuli in the heart. Created a GUI and have the user select where the stimulus originates within the heart allowing a visual representation for stimulus traveling through the neural structure of the heart. Adapted tractography program to use DW-MRI data, helping to visualize and model abnormalities within the structure of the heart. Integrated program application to allow modeling of heart muscles and movement for palpitations with 4D data. Presented research to superiors and peers in a professional setting. Show less