Les Bogdanowicz, Phd, Mba Email and Phone Number
Park Ridge, IL, US
Les Bogdanowicz, Phd, Mba's Location
Park Ridge, Illinois, United States, United States
Les Bogdanowicz, Phd, Mba's Contact Details
Les Bogdanowicz, Phd, Mba work email
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Les Bogdanowicz, Phd, Mba personal email
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About Les Bogdanowicz, Phd, Mba
As a seasoned executive manager in the medical device space, I lead the engineering development, clinical project management, regulatory affairs and team leadership for medical device companies with and emphasis on startups and early stage companies. I have ushered over 20 medical devices to market and have had multiple exits.My passion for medical device innovation stems from my academic background in electrical engineering, computer science, and bioengineering, as well as my personal experience as a patient and a caregiver. I have a PhD in Bioengineering from the University of Illinois at Chicago, where I also teach as an adjunct faculty and share my insights and skills with the next generation of bioentrepreneurs. I have also contributed to the advancement of the field through multiple patents, publications, and expert witness testimonies. My mission is to bring medical devices to life that can enhance the quality of care and the quality of life for patients and providers.
Les Bogdanowicz, Phd, Mba's Current Company Details
Les Bogdanowicz, Phd, Mba Work Experience Details
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Chief Technology OfficerOliPark Ridge, Il, Us
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Vp Quality Assurance And Regulatory AffairsCurative Sound May 2023 - PresentBuilding 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. -
Founding PartnerAgile Medical Device Design May 2012 - PresentChicago, Il, UsRegulatory 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 -
Adjunct FacultyUniversity Of Illinois At Chicago Department Of Bioengineering Jan 2014 - PresentChicago, Il, UsCrossing 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. -
Expert WitnessRobson Forensic, Inc. Nov 2019 - Apr 2024Lancaster, Pa, UsConduct forensic investigations related to injury causation and medical device failures. -
Cto/Vice President Of DevelopmentNovascan Nov 2018 - Mar 2024Chicago, Illinois, UsMedical 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. -
Director Of Electrical/Software EngineeringDesign Integrity, Inc. Jan 2018 - Feb 2021Chicago, Illinois, UsElectrical and Software design services for consumer, industrial and medical industries. -
Sr. Director Of Product DevelopmentEndotronix, Inc. Jun 2016 - Dec 2017Naperville, Illinois, UsBuilding 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) -
Chief Technology OfficerBold Diagnostics, Llc Jan 2016 - Sep 2017BOLD 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 -
Director Biomedical EngineeringOptimal Design 2015 - 2017Arlington Heights, Il, UsOptimal 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. -
Founder/PrincipalOcumed May 2002 - Dec 2013OcuMed is a privately held startup medical device company bringing therapeutic devices for patients suffering from blinding retinal degenerative diseases.
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Engineering ManagerZoll Medical Corporation Feb 2009 - May 2012Ma, 01824, UsPublic 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 -
Program ManagerWelch Allyn Oct 2005 - Feb 2009Skaneateles Falls, New York, UsPrivately 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 -
Engineering DirectorOptobionics Corporation Dec 1999 - Jul 2002UsVenture-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 -
Electronics DesignerRehkemper Id May 1996 - Dec 1999Chicago, Il, UsPrivately 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 -
Electrical EngineerAksys, Ltd. May 1994 - May 1996UsVenture-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.
Les Bogdanowicz, Phd, Mba Skills
Medical Devices
R&d
Product Development
Manufacturing
Fda
Product Design
Cross Functional Team Leadership
Embedded Systems
Electronics
Biomedical Engineering
Management
Engineering Management
Design Control
Product Launch
Iso 13485
Intellectual Property
Validation
Engineering
Product Lifecycle Management
Team Leadership
Automation
Electrical Engineering
Start Ups
Quality System
Biotechnology
Standards Compliance
Product Management
V&v
Design Of Experiments
Capa
Fmea
Research And Development Of New Products/services
Medical Device Product Design And Management
Building Strong Team Motivation And Engagement
Product Life Cycle Management
Compliance
Sailing
Corrective And Preventive Action
Failure Mode And Effects Analysis
Verification And Validation
U.s. Food And Drug Administration
Research And Development
Les Bogdanowicz, Phd, Mba Education Details
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University Of Illinois ChicagoBioengineering And Biomedical Engineering -
Depaul Driehaus College Of BusinessBiotechnology Management
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University Of Illinois ChicagoElectrical Engineering And Computer Science
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University Of Illinois ChicagoElectrical Engineering And Computer Science
Frequently Asked Questions about Les Bogdanowicz, Phd, Mba
What company does Les Bogdanowicz, Phd, Mba work for?
Les Bogdanowicz, Phd, Mba works for Oli
What is Les Bogdanowicz, Phd, Mba's role at the current company?
Les Bogdanowicz, Phd, Mba's current role is Chief Technology Officer.
What is Les Bogdanowicz, Phd, Mba's email address?
Les Bogdanowicz, Phd, Mba's email address is le****@****ech.com
What is Les Bogdanowicz, Phd, Mba's direct phone number?
Les Bogdanowicz, Phd, Mba's direct phone number is +131291*****
What schools did Les Bogdanowicz, Phd, Mba attend?
Les Bogdanowicz, Phd, Mba attended University Of Illinois Chicago, Depaul Driehaus College Of Business, University Of Illinois Chicago, University Of Illinois Chicago.
What are some of Les Bogdanowicz, Phd, Mba's interests?
Les Bogdanowicz, Phd, Mba has interest in Yacht Racing, Skiing, Entrepreneurial Ventures.
What skills is Les Bogdanowicz, Phd, Mba known for?
Les Bogdanowicz, Phd, Mba has skills like Medical Devices, R&d, Product Development, Manufacturing, Fda, Product Design, Cross Functional Team Leadership, Embedded Systems, Electronics, Biomedical Engineering, Management, Engineering Management.
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