Yohannes Iyassu
Vice President Research And Development at Micro-Leads, Inc.- Claim this Profile
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Bio
Experience
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Micro-Leads Medical
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Vice President Research And Development
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Feb 2020 - Present
Micro-Leads is developing next generation Spinal Cord Stimulation (SCS) system and undergoing a clinical trial for wider coverage and selective targeting therapy for patients with chronic pain. We developed an industry first active lead with a hermetic multiplexer and a minimally invasive injectable paddle lead. - Direct the R&D team in systems, electronics, mechanical, and firmware/software engineering with standards-based Class III implantable medical device development, testing, and… Show more Micro-Leads is developing next generation Spinal Cord Stimulation (SCS) system and undergoing a clinical trial for wider coverage and selective targeting therapy for patients with chronic pain. We developed an industry first active lead with a hermetic multiplexer and a minimally invasive injectable paddle lead. - Direct the R&D team in systems, electronics, mechanical, and firmware/software engineering with standards-based Class III implantable medical device development, testing, and maintenance. - Direct and outlin a roadmap for the team to define scoped and 100% traceable deliverables of user needs, risk management, design inputs, design outputs, verification and validation. - Restructured ∼80% development and QMS SOPs for better alignment of deliverables and standards by scoping requirements to the intended indication and submission. - Engage with regulatory bodies on a quarterly basis to align development with submission, received IDE and IRB approval for a significant risk - safety and efficacy - study. Show less Micro-Leads is developing next generation Spinal Cord Stimulation (SCS) system and undergoing a clinical trial for wider coverage and selective targeting therapy for patients with chronic pain. We developed an industry first active lead with a hermetic multiplexer and a minimally invasive injectable paddle lead. - Direct the R&D team in systems, electronics, mechanical, and firmware/software engineering with standards-based Class III implantable medical device development, testing, and… Show more Micro-Leads is developing next generation Spinal Cord Stimulation (SCS) system and undergoing a clinical trial for wider coverage and selective targeting therapy for patients with chronic pain. We developed an industry first active lead with a hermetic multiplexer and a minimally invasive injectable paddle lead. - Direct the R&D team in systems, electronics, mechanical, and firmware/software engineering with standards-based Class III implantable medical device development, testing, and maintenance. - Direct and outlin a roadmap for the team to define scoped and 100% traceable deliverables of user needs, risk management, design inputs, design outputs, verification and validation. - Restructured ∼80% development and QMS SOPs for better alignment of deliverables and standards by scoping requirements to the intended indication and submission. - Engage with regulatory bodies on a quarterly basis to align development with submission, received IDE and IRB approval for a significant risk - safety and efficacy - study. Show less
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Nuvectra
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Executive Director - Electrical, Software, and Test Systems Engineering
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Mar 2018 - Feb 2020
Nuvectra developed a Neuromodulation Implantable System platform to be used in SCS, Sacral Nerve Stimulation (SNS), and Deep Brain Stimulation (DBS) therapies. Nuvectra achieved double digit growth and ∼1000 implants per year to treat patients with chronic pain. - Directed 4 cross-disciplinary departments: Electronics/Software Engineering, Us- ability Engineering, Labelling, and Manufacturing Test Systems. - Completed 2nd generation stimulation ASIC within 18 months in collaboration… Show more Nuvectra developed a Neuromodulation Implantable System platform to be used in SCS, Sacral Nerve Stimulation (SNS), and Deep Brain Stimulation (DBS) therapies. Nuvectra achieved double digit growth and ∼1000 implants per year to treat patients with chronic pain. - Directed 4 cross-disciplinary departments: Electronics/Software Engineering, Us- ability Engineering, Labelling, and Manufacturing Test Systems. - Completed 2nd generation stimulation ASIC within 18 months in collaboration with critical sup- plier/chip manufacturer: 4x performance improvement. - Received FDA approval for SCS system, and CE mark for Deep Brain Stimulation (DBS) system (Collaboration with Aleva Neurotherapeutics). - Proposed and led a company wide multi-stage initiative to transform legacy system components with modern platforms.
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Director of Engineering - Electrical, Software Engineering and Test Systems
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Sep 2017 - Mar 2018
Direct the engineering team - electrical and software design and development for Class III Medical Im- plantable Electronic Systems. Direct the team in prototyping, designing, developing, testing, releasing, and maintaining Spinal Cord Stimulation (SCS) and Sacral Nerve Stimulation (SNS) systems.
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Director, Software Engineering
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Mar 2016 - Sep 2017
Responsible for software/firmware development within the organization. Direct the engineering team in prototyping, developing, releasing, and maintaining software systems.
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QiG Group/Nuvectra
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Greater Denver Area
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Principal R&D Engineer
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Mar 2010 - Feb 2016
Design and development of low-level, middle-tier and application layer software for medical devices. - Interpreted business requirements and develop traceable documentation including user interface, functional requirements and specifications, architectures, software designs including algorithms, design verification and validation tests. - Interacted with key opinion leaders such as physicians, nurses, and sales representatives to capture user needs. - Managed software development… Show more Design and development of low-level, middle-tier and application layer software for medical devices. - Interpreted business requirements and develop traceable documentation including user interface, functional requirements and specifications, architectures, software designs including algorithms, design verification and validation tests. - Interacted with key opinion leaders such as physicians, nurses, and sales representatives to capture user needs. - Managed software development projects in Neuromodulation (Spinal Cord Stimulation, Sacral Nerve Stimulation) and Cardiology. - Provided technical expertise to evaluate partners as well as up-and-coming technology for medical devices. Show less Design and development of low-level, middle-tier and application layer software for medical devices. - Interpreted business requirements and develop traceable documentation including user interface, functional requirements and specifications, architectures, software designs including algorithms, design verification and validation tests. - Interacted with key opinion leaders such as physicians, nurses, and sales representatives to capture user needs. - Managed software development… Show more Design and development of low-level, middle-tier and application layer software for medical devices. - Interpreted business requirements and develop traceable documentation including user interface, functional requirements and specifications, architectures, software designs including algorithms, design verification and validation tests. - Interacted with key opinion leaders such as physicians, nurses, and sales representatives to capture user needs. - Managed software development projects in Neuromodulation (Spinal Cord Stimulation, Sacral Nerve Stimulation) and Cardiology. - Provided technical expertise to evaluate partners as well as up-and-coming technology for medical devices. Show less
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EBSNet Inc.
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Littleton, MA
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Firmware/Software Engineer
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Jun 2003 - Mar 2010
Embedded systems development and maintenance of a proprietary operating system, networking protocols, and firmware. - Firmware software design and development (bootstrap, interrupt routines, device drivers) for the ARM7, ARM9, COLDFIRE, MPC860 and PowerPC architectures. - .Net Micro-framework\texttrademark and TCP/IP integration. - Real-Time Operating System and Network Protocol development and maintenance : CIFS/SMB, SSL (a port of OpenSSL), TCP/IP, RTOS and other network… Show more Embedded systems development and maintenance of a proprietary operating system, networking protocols, and firmware. - Firmware software design and development (bootstrap, interrupt routines, device drivers) for the ARM7, ARM9, COLDFIRE, MPC860 and PowerPC architectures. - .Net Micro-framework\texttrademark and TCP/IP integration. - Real-Time Operating System and Network Protocol development and maintenance : CIFS/SMB, SSL (a port of OpenSSL), TCP/IP, RTOS and other network protocols. - Interface and platform design for industry standard testing utility (TAHI, IPv6 Ready Logo test suite) for embedded devices. - Device drivers development for embedded and Real-Time Operating Systems. Show less Embedded systems development and maintenance of a proprietary operating system, networking protocols, and firmware. - Firmware software design and development (bootstrap, interrupt routines, device drivers) for the ARM7, ARM9, COLDFIRE, MPC860 and PowerPC architectures. - .Net Micro-framework\texttrademark and TCP/IP integration. - Real-Time Operating System and Network Protocol development and maintenance : CIFS/SMB, SSL (a port of OpenSSL), TCP/IP, RTOS and other network… Show more Embedded systems development and maintenance of a proprietary operating system, networking protocols, and firmware. - Firmware software design and development (bootstrap, interrupt routines, device drivers) for the ARM7, ARM9, COLDFIRE, MPC860 and PowerPC architectures. - .Net Micro-framework\texttrademark and TCP/IP integration. - Real-Time Operating System and Network Protocol development and maintenance : CIFS/SMB, SSL (a port of OpenSSL), TCP/IP, RTOS and other network protocols. - Interface and platform design for industry standard testing utility (TAHI, IPv6 Ready Logo test suite) for embedded devices. - Device drivers development for embedded and Real-Time Operating Systems. Show less
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University of Massachusetts Lowell
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United States
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Higher Education
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700 & Above Employee
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Adjunct Professor
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Jan 2007 - Jun 2008
Professor of Network Design and Operating Systems Professor of Network Design and Operating Systems
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University of Massachusetts Lowell
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United States
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Higher Education
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700 & Above Employee
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Graduate Research Assistant
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Sep 2001 - Jun 2003
Image processing, machine learning and distributed systems research assistant for Professor Dalila Megherbi. Image processing, machine learning and distributed systems research assistant for Professor Dalila Megherbi.
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Galileo Consulting
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Denver, CO
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Software Engineer
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Jun 2000 - Sep 2001
Biomedical signal processing for a surgical spinal positioning device equipment. - Animal laboratory experiment research and analysis. - Virtual Instrument design and implementation for animal laboratory experiments and proof of concept. - Signal processing design techniques to be used on an EMG response waveform to extract useful information. - Algorithm design and implementation to provide minimally invasive spinal surgeries. Biomedical signal processing for a surgical spinal positioning device equipment. - Animal laboratory experiment research and analysis. - Virtual Instrument design and implementation for animal laboratory experiments and proof of concept. - Signal processing design techniques to be used on an EMG response waveform to extract useful information. - Algorithm design and implementation to provide minimally invasive spinal surgeries.
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University of Denver
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United States
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Higher Education
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700 & Above Employee
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Graduate Teaching Assistant
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Sep 1999 - Jun 2001
Network Design, Operating Systems, Microprocessors I and II, Electronics I, and Advanced Digital Design teaching assistant. Network Design, Operating Systems, Microprocessors I and II, Electronics I, and Advanced Digital Design teaching assistant.
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University of Denver
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United States
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Higher Education
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700 & Above Employee
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Undergraduate Research Assistant
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Sep 1998 - Jun 1999
Microprocessors I and II teaching assistant. Microprocessors I and II teaching assistant.
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TÜV Product Service
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Boulder, CO
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Summer Intern
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Jun 1996 - Sep 1996
Test Engineer for Electromagnetic Compatibility. - Radiation Immunity/Emission Testing, Surge Testing, and Electro Static Discharge Testing. - Peak detector design and development for a power line. Test Engineer for Electromagnetic Compatibility. - Radiation Immunity/Emission Testing, Surge Testing, and Electro Static Discharge Testing. - Peak detector design and development for a power line.
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Education
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University of Massachusetts at Lowell
Doctoral of Engineering (PhD), Electrical and Computer Engineering -
University of Denver
Master of Science (M.S.), Electrical and Computer Engineering -
University of Denver
Bachelor of Science (B.S.), Electrical Engineering