Les Bogdanowicz, Phd, Mba Email & Phone Number

Park Ridge, Il, Us

Building QMS providing regulatory strategy and regulatory filings for extracorporeal shock wave therapy (ESWT) devices with Curative Sound.Curative Sound is an emerging therapeutic ultrasound company. The products produce high-energy acoustical “shock waves” called ESWT that non-invasively repair and regenerate skin, musculoskeletal and vascular structures.ESWT is an emerging modality in “regenerative medicine.” The pressure waveform is similar to that used in Lithotripsy (to break up kidney stones), but at a much lower intensity. The Curative Sounds products are state-of-the-art, portable handheld devices that produces high-pressure, focused, acoustic shock waves. It was designed to provide health care professionals an effective and easy-to-use device for administering the latest and most advanced “focused” ESWT; an evidence-based therapy used across multiple orthopedic and wound healing indications. Focused acoustic shock waves trigger a biological healing response in tissue by the shear and pressure forces they produce.

Chicago, Il, Us

Regulatory strategy, IP strategy and development strategy for Aeris Surgical, a device to improve end tidal CO2 measurements during sedation.Advanced technology development in medical devices/consumer electronics. Requirements management in Jama. Engineering Leadership role with Endotronix July 2016 - Dec 2017Contract work With Garret Technologies May 2012 - Oct 2015Optical System design for NanoCytomics Cancer screening system.• AOTF design and integration with high output Xenon lighting system for epi-flourescence.System Engineering for next generation Hospira Infusion pump.• Ground up requirements authoring• User Interface designAdvanced Sensor design for Hospira Infusion Pump• Optical sensor design for fluid monitoringDesigned Electronics and Software for Evenflo's Advanced Dual Breast Pump• Circuit design, Embedded System design, design for manufacturing• Full Systems Engineering - from Use Case authoring, Requirements authoring to Verification and Validation• Support for 510K filingDesign of ECG front end pick up for Abiomed Symphony Heart Assist Pump• Circuit Design, Data Analysis, Animal TrialsLead designer of Intel Elkhorn Mountain Medical Device Reference Design• Implementing Intel/Apple Thunderbolt port technology• PCIe, SATA, USB 3.0, LVDS, projective capacitive touch interface, MiPi Camera interface, Audio 7.1, Com Express, Near Fear Communication (NFC), Accelerometer, GPS, GYRO• Multi-core virtualized machine

Chicago, Il, Us

Crossing the fence between academia and industry. Instructor and lecturer for the bioentrepreneur and medical device industry 'skill sets' classes on medical device design, product development, ISO & FDA requirements, emerging medical technologies, and medical device commercialization.

Lancaster, Pa, Us

Conduct forensic investigations related to injury causation and medical device failures.

Chicago, Illinois, Us

Medical device startup developing technologies and products for the stratification of cancer with a simplified modality. Providing structured engineering development, clinical project management and team leadership/management.

Chicago, Illinois, Us

Electrical and Software design services for consumer, industrial and medical industries.

Naperville, Illinois, Us

Building an engineering team to manage requirements, compliance, risk management, regulatory, verification and validation for a complex medical device and patient management service.Roll out of Jama requirements management tool (RMT)

BOLD diagnostics is a startup providing a novel solution to managing hypertension. We are a NSF SBIR backed company for which I serve as the Primary Investigator.Primary Investigator (PI) - NSF SBIR Grant Award ID 1621937

Arlington Heights, Il, Us

Optimal Design is a first class engineering and design firm providing the latest technology offerings in virtual reality (VR), internet of things (IoT), and various mechatronics solutions. Brought aboard to grow the medical device/life sciences expertise offering.Designed connected wearable mouthguard fro SMART mouth.Designed electronics for Sage next generation AirTap device.

OcuMed is a privately held startup medical device company bringing therapeutic devices for patients suffering from blinding retinal degenerative diseases.

Ma, 01824, Us

Public company focused on resuscitation products. Involved with the divestiture of Propaq technology group from Welch Allyn to ZOLL. Completed product development on next generation Propaq – a portable monitor defibrillator for the U.S. Military. Research in advanced algorithms for automated decision support.• Advanced algorithm research in the detection of cardiac disease and trauma prediction Completed delivery of five year R&D effort• Managing seven direct reports, ten indirect reports• Standards Compliance 60601-1, 1-2, 2-34, 1-26, Military Standards Compliance MIL-STD461, Airworthiness Testing RTCA DO-160. Managed certification with internal and external resources to meet project timelines and project budgets.• Transfer of system architecture design to other internal product teams to accelerate the time to market of other development efforts. This product architecture is ZOLL’s basic architecture for all future resuscitation products

Skaneateles Falls, New York, Us

Privately held medical device company focused on front line care. Involved with the research and development of merged company technologies into new products. Specifically hired to lead a team in the development of a new portable monitor defibrillator utilizing core technologies across the organization. Managed the product development with talent residing in several different countries. This program group was divested to ZOLL Medical.• Managed eight direct reports, fifteen indirect reports – cross geographic resources• Lead Designer and Product Architect for next generation Propaq Monitor Defibrillator. Technology developed is being utilized going forward as ZOLL’s platform technology. • Developed requirements from customer needs, managed requirements through out development cycle with Requisite Pro.• Administered development tools; Orcad CIS with SAP, Rational Tools Suite

Us

Venture-backed research and development firm established to develop a device to restore vision to blind patients. Recruited by the CEO and founder of the company as the first employee of the company to develop the first implanted retinal chip to restore vision to blind patients. Managed a team of six engineers and researchers, and several outside researchers and consultants. Conducted animal research and human trials under an FDA IDE. Coordinated clinical tests for multi-site PMA clinical trials. • Development of implantable silicon chip, development of process, manufacture and test of device, Materials research• Conducted animal trials with device with the Illinois VA, University of Illinois and the Cleveland VA• Chartered research and development facilities at Howard University, University of Illinois and Stanford University; Conducted research at all locations• Contributed to the development business plans and presentations to investors; Integrally involved in the raising of $6 million round C funding and $28 million round D funding• Involved with patent litigation; strategically blocking opponents’ patents• Managed Clinical trials under a IDE PMA

Chicago, Il, Us

Privately held firm specializing in the invention and design of toys. Hired by the company’s founders to research and develop electronic consumer products. Managed a team of four engineers and technicians, oversaw electronic design, software design and mechanical design. Traveled to Honk Kong, China and Taiwan to support clients’ manufacturing needs; sought out regulatory approval on products through CE and TUV.• Licensed 18 toy designs including “Make Believe Elmo,” Christmas 2000 Top 10 Toy List

Us

Venture-backed startup medical device company founded to develop a fully automated kidney dialysis machine. Recruited by the Vice President of Engineering. Involved in the research and design of software and electronics for the home dialysis machine; provided manufacturing support for electronic and mechanical design. Conducted FMEAs on system, subsystem and component levels. Designed safety systems, specifically air bubble detectors and blood leak detectors.

Doctor Of Philosophy (Phd), Bioengineering And Biomedical Engineering

Mba, Biotechnology Management

Master’S Degree, Electrical Engineering And Computer Science

Bachelors Of Science, Electrical Engineering And Computer Science