Expert Details
Lasers and Electro Optics
ID: 731644
Minnesota, USA
As a laser and electro optic technology specialist I’ve been an ongoing engineering, application, regulatory and safety resource for manufacturers, system integrators, researchers and end users of lasers, electro optics and light based instrumentation used in manufacturing, medical, industrial, research and scientific.
• Design, development and application of lasers, manufacturing systems, robotic cells and automated industrial systems in compliance with 21CFR 1040.10 Federal Laser Product Performance Standards
• Regulatory and safety support for laser product compliance (i.e. ANSI, European [EN 207 & 208], IEC-60825, IEC-60601-2-22, ITAR, MIL-STD, etc), due diligence research, hazard analysis of radiation fields, etc
• Engineering, R&D and regulatory compliance efforts for laser and light based medical devices
• Supported the set-up, operation, instrumentation and clinical application of cardiovascular procedures (lead extractions & laser angioplasty, trans myocardial laser revascularization [TMRs], endovenous laser treatment [EVLT], cutaneous vascular laser treatments) at centers across North America
• Supported the set-up, operation, instrumentation and clinical application of thousands of laser and light based procedures involving all medical, surgical, endoscopic, ophthalmic and outpatient specialties at centers across North America
• Regulatory and safety support specialist for FDA, CDRH, ANSI, EN, Investigational New Drug (IND), New Drug Application (NDA), 510(k), IDE and PMA compliance, due diligence research, quantitative analysis of adverse patient/treatment outcomes or laser ‘events’, laser radiation fields, clinical case report form (CRF) development, etc
• Research, design and development of certified laser products in compliance with 21CFR 1040.10 Federal Laser Product Performance Standards and complete/submit FDA form 3632 required for accession number for sale and distribution
• Engineering, R&D and regulatory compliance support for laser manufacturers and light based medical devices
• US R&D, engineering, clinical application, medical staff trainer, technical and regulatory specialist for the US Phase II multi-center clinical studies of a lasers, treatment fiber optics and instrumentation for use with light activated drug for treatment of Age Related Macular Degeneration and Prostate Cancer (safety & dose escalation) for Steba Biotech S.A. that have concluded.
• Clinical application, technical, regulatory, safety and engineering specialist for North American preclinical research (Photodynamic therapy to the oral cavity, tongue and larynx: a canine normal tissue tolerance study, Effect of low-dose argon irradiation on rate of wound closure, others) and FDA approved Phase II and Phase III multi-center studies, medical lasers, treatment fiber optics and light based instrumentation and surgical navigation platforms
• Clinical application and technical support specialist for the R&D of medical lasers, fiber optics, instrumentation and treatments involving fluorescence endoscopy and photodynamic therapy treatment (Photofrin) of lung, Barrett's Esophagus (high grade dysplasia [HGD]), urinary bladder, metastatic chest, head & neck, cholangiocarcinoma and other cancers
• Faculty and instructor for accredited laser training programs (i.e. didactic, ‘hands-on’, animal and cadaver labs) and regulatory compliance audits for physicians, medical staff and clinical engineers on behalf of Association for the Advancement of Medical Instrumentation (AAMI), AORN, the Laser Institute of America, American Society for Laser Medicine and Surgery, Physicians Forum/National Speakers Program, university medical centers, hospitals and others
• Assembled, installed, operated, maintained and repaired medical lasers and electro optical instrumentation at sites across North America including the Spectranetics CVX-300
• Testing & labeling of laser products and
• Development and line-by-line prepublication editorial review of the ANSI Z136 standards (series)
He provides research, design and development of safety controls for CDRH certified laser products and robotic cells in compliance with 21CFR 1040.10 Federal Laser Product Performance Standards and complete/submit FDA form 3632 required for accession number to sell and distribute laser systems He provides regulatory and safety support for laser product compliance (i.e. ANSI, European [EN 207 & 208], IEC-60825, IEC-60601-2-22, ITAR, MIL-STD, etc), due diligence research, analysis of laser radiation fields, etcHe provides engineering, R&D and regulatory compliance efforts for manufacturers of laser and light based medical devicesHe provides R&D and clinical application support of medical lasers, treatment fiber optics and instrumentation for US research centers involved in preclinical, Phase II and Phase III multi-center studies He has assembled, installed, operated, maintained and repaired medical lasers (i.e. CO2, argon, krypton, copper vapor, gold vapor, excimer, HeNe, liquid tunable dye, Nd:YAG, Ho:YAG, ruby, alexandrite, semiconductor/diode, KTP, IPL’s and others) and electro optical instrumentation at sites across North America in lieu of service contracts
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1985 | Degree: Associate in Applied Science | Subject: Laser and Electro Optic Techology | Institution: North Central Technical Institute |
| Year: 1982 | Degree: Associate in Applied Science | Subject: Marketing | Institution: North Central Technical Institute |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2012 to 2013 | Employer: (Undisclosed) | Title: Laser Consulting and Contract Services | Department: (Undisclosed) |
Responsibilities:R&D, engineering, application, process automation, safety controls development, independent and 3rd party technical service for manufacturers, system integrators and end users of lasers and electro optic instrumentation, Support manufacturers and system integrators in the design, development and applications of lasers, manufacturing systems, robotic cells and products in compliance with Federal Laser Product Performance Standards and prepare/submit required regulatory documentation and reportsAbbreviated list of recent R&D, consulting, engineering, product development, 3rd party technical/service, employee training, due diligence research, safety and regulatory compliance projects, clients and venues: ABB Robotics - North America, ADC Telecommunications, Advanced Photodynamic Technologies, Association for the Advancement of Medical Instrumentation, American Society of Safety Engineers (ASSE), Biolitec (Germany), Boston Scientific, Cannon Equipment, Carl Zeiss Micro Imaging Inc., Coloplast, Cybersmith Engineering, Ellison Technologies Automation, Engineering Technology Institute, Greatbatch Medical, Hennepin County Medical Center, IPG Photonics, Johns Hopkins-Wilmer Eye Institute, Kentek Inc., Laser Safety Ind., Laserman Inc., LasX, Mayo Hospitals & Clinics, Medlight (Switzerland), Medtronic, Meggitt Defense Industries, Memorial Sloan-Kettering Cancer Center, MinVasive Surgical Partners, NASA - Kennedy Space Center, North Central Biomedical Association, NYU Medical Center, Rudolph Technologies, ThyssenKrupp Inc., Tri-State Manufacturing Association, UCLA-Jonsson Comprehensive Cancer Center, Universal Hospital Services (UHS), University of Minnesota Center for Research in Education and Simulation Technologies (CREST), University of Missouri School of Medicine, US Air Force, VA Medical Centers-VISN 23, VGen Electro Optics (Israel), Viracon Inc., Washington University School of Medicine, Westinghouse Electric Corp. (Nuclear Energy), Wisconsin Safety Council, Young Solutions, Inc. |
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| Years | Employer | Title | Department |
| Years: 2009 to 2012 | Employer: (Undisclosed) | Title: US Laser Research & Engineering Support Manager | Department: (Undisclosed) |
Responsibilities:StebaTech (NY) is a division of Steba Biotech (France) conducting US studies of a laser light activated drug per FDA approved protocols for prostate cancer and age related macular degeneration at multiple US research centers and supplies all investigators with lasers, fiber optics and instrumentation required for studies. Essential functions include: Engineering, application, regulatory and logistical support for manufacturers and researchers in the R&D of lasers, fiber optics and electro optical instrumentation. Managed and serviced US inventory and installed base of lasers (i.e. install, operate, calibrate, software/hardware upgrades, program/configure, engineering change orders [ECOs], etc), fiber optics and instrumentation. Supported US researchers and centers for protocol and project compliance. On site application support and trainer for researchers, engineers and end users. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2008 | Employer: (Undisclosed) | Title: Product Manager and OEM consultant | Department: (Undisclosed) |
Responsibilities:Laservision manufactures laser safety products and provides safety and regulatory compliance services for customers. Essential functions included: Defined customer requirements in a consultative sales environment and developed laser products and solutions exceeding industry and regulatory standards. Scanned, tested and certified filters and materials for optical properties (UV, VIS, NIR) and laser damage thresholds per applicable regulatory compliance standards (i.e. ANSI, European [EN 207 & 208], IEC-60825, IEC-60601-2-22, ITAR, MIL-STD, CSA, etc), Developed/presented accredited E-based training products, programs, product specifications, white papers, articles, etc. Conducted regulatory compliance audits, prepared CDRH laser product reports, regulatory submissions and hazard assessments for OEM customers and end users of lasers |
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| Years | Employer | Title | Department |
| Years: 2003 to 2008 | Employer: (Undisclosed) | Title: North American Laser Research, Engineering & Support: Contract Position | Department: (Undisclosed) |
Responsibilities:Engineering, application, regulatory and logistical support for manufacturers, business partners and researchers in the R&D of lasers, fiber optics and light based instrumentation. Managed and serviced inventory and installed base of lasers (i.e. install, operate, calibrate, software/hardware upgrades, program/configure, engineering change orders [ECOs], etc), fiber optics and instrumentation. Supported research projects, training and applications for FDA/CDRH protocol compliance and light dosimetry parameters. On site application support and trainer for researchers, engineers and end users. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2003 | Employer: (Undisclosed) | Title: US Laser Application Support Manager | Department: (Undisclosed) |
Responsibilities:Engineering, application, regulatory and sales support for distributors, sales representatives and end users. Managed and serviced US inventory and installed base of lasers (i.e. install, operate, calibrate, software/hardware upgrades, program/configure, engineering change orders [ECOs], etc), fiber optics and electro optic instrumentation |
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| Years | Employer | Title | Department |
| Years: 1990 to 2000 | Employer: (Undisclosed) | Title: Laser and Electro Optic Specialist | Department: (Undisclosed) |
Responsibilities:System wide technical, engineering and application support specialist for lasers, electro optics and other light-based instrumentation. Operated maintained, aligned, calibrated, repaired and upgraded entire inventory of lasers and intense pulse light sources (IPL) in lieu of costly annual service contracts. |
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Career Accomplishments
| Associations / Societies |
|---|
| American Society for Laser Medicine and Surgery, Laser Institute of America, ANSI Z136 Standards Committees: ANSI Z136 Laser Control Measures, technical subcommittee (TSC4) ANSI Z136.3 Safe Use of Lasers in Health Care, standards subcommittee (SSC3) ANSI Z136.7 Testing and Labeling of Laser Protective Equipment, standards subcommittee (SSC7) ANSI Z136 Safe Use of Lasers series Editorial Working Group (EWG): 136.1 Safe Use of Lasers, 136.2 Safe Use of Optical Fiber Communications Systems Utilizing Laser Diode and LED Sources,136.3 Safe Use of Lasers in Health Care,136.4 Measurements and Instrumentation,136.5 Safe Use of Lasers in Educational Institutions,136.6 Safe Use of Lasers Outdoors,136.7 Eyewear and Protective Barriers,136.8 Safe Use of Lasers in Research, Development & Testing,136.9 Safe Use of Lasers in Manufacturing Environments,136.10 Safe Use of Lasers in Entertainment, Displays and Exhibitions |
| Licenses / Certifications |
|---|
| Certified Laser Safety Officer/Board of Laser Safety |
| Professional Appointments |
|---|
| Member: Laser Institute of America ANSI Z136 Laser Control Measures, technical subcommittee (TSC4) ANSI Z136.3 Safe Use of Lasers in Health Care, standards subcommittee (SSC3) ANSI Z136.7 Testing and Labeling of Laser Protective Equipment, standards subcommittee (SSC7) ANSI Z136 Safe Use of Lasers series Editorial Working Group (EWG): • ANSI Z136.1 - Safe Use of Lasers • ANSI Z136.2 - Safe Use of Optical Fiber Communication Systems Utilizing Laser Diode and LED Sources • ANSI Z136.3 - Safe Use of Lasers in Health Care • ANSI Z136.4 - Recommended Practice for Laser Safety Measurements • ANSI Z136.5 - Safe Use Of Lasers In Educational Institutions • ANSI Z136.6 - Safe Use Of Lasers Outdoors • ANSI Z136.8 - Safe Use of Lasers in Research, Development or Testing • ANSI Z136.9 - Safe Use of Lasers in Manufacturing Environments |
Additional Experience
| Training / Seminars |
|---|
| ABB Robotics - North America, ADC Telecommunications, Advanced Photodynamic Technologies, Association for the Advancement of Medical Instrumentation, American Society for Laser Medicine and Surgery (multiple US programs/projects), American Society of Safety Engineers (ASSE), Biolitec (Germany), Boston Scientific, Cannon Equipment, Carl Zeiss Micro Imaging Inc., Coloplast, Cybersmith Engineering, Ellison Technologies Automation, Engineering Technology Institute, Greatbatch Medical, Hennepin County Medical Center, IPG Photonics, Johns Hopkins-Wilmer Eye Institute, Kentek Inc. (multiple US programs/projects), Laser Institute of America (multiple US programs/projects), Laser Safety Ind., Laserman Inc., LasX, Mayo Hospitals & Clinics, Medlight (Switzerland), Medtronic, Meggitt Defense Industries, Memorial Sloan-Kettering Cancer Center, MinVasive Surgical Partners, NASA - Kennedy Space Center, North Central Biomedical Association, NYU Medical Center, Physicians Forum/National Speakers Program (multiple US programs/projects), Rudolph Technologies, ThyssenKrupp Inc., Tri-State Manufacturing Association, UCLA-Jonsson Comprehensive Cancer Center, Universal Hospital Services (UHS) , University of Minnesota Center for Research in Education and Simulation Technologies (CREST), University of Missouri School of Medicine, US Air Force, VA Medical Centers-VISN 23, VGen Electro Optics (Israel), Viracon Inc., Washington University School of Medicine, Westinghouse Electric Corp. (Nuclear Energy), Wisconsin Safety Council, Young Solutions, Inc. |
| Other Relevant Experience |
|---|
| R&D, consulting, engineering, product development, 3rd party technical/service, employee training, due diligence research, safety and regulatory compliance projects, programs and technical support at multiple North American locations. Member Laser Institute of America American Society for Laser Medicine and Surgery ANSI Z136 Laser Control Measures, technical subcommittee (TSC4) ANSI Z136.3 Safe Use of Lasers in Health Care, standards subcommittee (SSC3) ANSI Z136.7 Testing and Labeling of Laser Protective Equipment, standards subcommittee (SSC7) ANSI Z136 Safe Use of Lasers series Editorial Working Group (EWG): |
Fields of Expertise
aiming beam, cosmetic laser surgery, Food and Drug Administration laser safety regulation, laser angioplasty, laser cavity, laser corneal surgery, laser enclosure, laser human health effect, laser measurement, laser operation, laser ophthalmology, laser safety, laser safety regulation, laser safety training, light coagulation, liquid laser, low-level laser therapy, medical laser, clinical engineering, photorefractive keratectomy, laser in-situ keratomileusis, laser weld, laser diagnostics, fiber laser, laser rangefinder, laser light scattering, near-infrared laser, laser-triggered spark gap, laser diode modulation, laser inspection, laser beam, laser ablation, active region, acoustophotorefractive effect, ablation threshold, industrial laser, laser metal processing, laser welder, pulsed ultraviolet laser, acceleration, carbon dioxide laser, argon-ion laser, YAG laser, laser interferometer, laser interferometry, laser optics, laser fabrication, nonmetal laser cutting, metal laser cutting, laser engraving, laser dye, laser spectroscopy, semiconductor laser, laser-produced plasma, laser-material interaction, optically pumped solid-state laser, laser-induced fluorescence, laser optical material, laser-induced damage, laser-induced optical component damage, laser application, continuous wave laser, laser etching, laser marking, acoustooptics, ultraviolet laser, dye laser, laser welding, tunable laser, solid-state laser, ruby laser, Q-switched laser, pulsed laser, laser, laser processing, laser materials processing, laser machining, laser glass, laser alignment system, infrared laser, gas laser, gallium arsenide laser, excimer laser, crystal laser, argon laser