Yohannes Iyassu

Vice President Research And Development at Micro-Leads, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Denver Metropolitan Area

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Vice President Research And Development
      • 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

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Executive Director - Electrical, Software, and Test Systems Engineering
      • 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.

    • Director of Engineering - Electrical, Software Engineering and Test Systems
      • 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.

    • Director, Software Engineering
      • Mar 2016 - Sep 2017

      Responsible for software/firmware development within the organization. Direct the engineering team in prototyping, developing, releasing, and maintaining software systems.

  • QiG Group/Nuvectra
    • Greater Denver Area
    • Principal R&D Engineer
      • 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

  • EBSNet Inc.
    • Littleton, MA
    • Firmware/Software Engineer
      • 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

    • United States
    • Higher Education
    • 700 & Above Employee
    • Adjunct Professor
      • Jan 2007 - Jun 2008

      Professor of Network Design and Operating Systems Professor of Network Design and Operating Systems

    • United States
    • Higher Education
    • 700 & Above Employee
    • Graduate Research Assistant
      • 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.

    • Software Engineer
      • 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.

    • United States
    • Higher Education
    • 700 & Above Employee
    • Graduate Teaching Assistant
      • 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.

    • United States
    • Higher Education
    • 700 & Above Employee
    • Undergraduate Research Assistant
      • Sep 1998 - Jun 1999

      Microprocessors I and II teaching assistant. Microprocessors I and II teaching assistant.

    • Summer Intern
      • 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.

Education

  • University of Massachusetts at Lowell
    Doctoral of Engineering (PhD), Electrical and Computer Engineering
    2001 - 2007
  • University of Denver
    Master of Science (M.S.), Electrical and Computer Engineering
    1999 - 2001
  • University of Denver
    Bachelor of Science (B.S.), Electrical Engineering
    1995 - 1999

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