Advanced Bionics, LLC
Industry: Company
DescriptionHeadquarters: California Founder: Alfred E. Mann Founded: 1993 Subsidiaries: Advanced Bionics UK Ltd., Advanced Bionics SARL, Parent organization: Sonova
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Advanced Bionics, LLC Employees
Baxter Healthcare September 2012 - Present
Baxter Healthcare April 2011 - February 2012
ADVANCED BIONICS LLC July 2010 - January 2011
Amgen November 2006 - July 2009
Amgen June 2005 - December 2007
Amgen September 2002 - June 2005
Amgen, Inc (thru Yoh Scientific) March 2002 - September 2002
Stanford Personal Care January 2001 - January 2002
Miravant Medical Technologies January 2000 - January 2001
Skills
GCP, GLP, Document Management, Metrics, GMP, Validation, FDA, Sop, Quality System, LIMS, Aseptic Processing, Clinical Development, CAPA, Drug Discovery, Microbiology, 21 CFR Part 11, Change Control, V&V, Quality Control, Regulatory Affairs, Biotechnology, Pharmaceutical Industry, Quality Auditing, Biopharmaceuticals, GxP, SOP
Education
University of California, Santa Barbara 1996 — 2001
B.S., Biological Psychology
University of California, Santa Barbara
Bachelor of Science (B.S.), Biopsychology
Valencia Technologies Corporation September 2011 - Present
Home April 2010 - November 2012
Advanced Bionics, LLC June 1998 - April 2010
Skills
Commercialization, Patents, Intellectual Property, Biomedical Engineering, Medical Devices, ISO 13485, Biotechnology, Regulatory Affairs, Start-ups, Technology Transfer, R&D, Lifesciences, Hardware Diagnostics, Patent Prosecution, FDA, Validation, Patent Litigation, Patentability, Licensing
Education
University of Utah 1976 — 1979
JD, Law
Southern Methodist University 1975 — 1976
Master's Degree, Electrical and Electronics Engineering
Brigham Young University
Engineering
Advanced Bionics September 2010 - Present
Advanced Bionics LLC February 2001 - September 2010
Westside Packaging, Inc. July 1999 - February 2001
Skills
Medical Devices, Product Development, FDA, Product Launch, Design Control, ISO 13485, Capital Equipment, Cross-functional Team..., Product Management, R&D, Product Lifecycle..., Commercialization, Market Development, Quality System, Biomedical Engineering, CAPA, Global Marketing, Validation, Manufacturing, Biotechnology, Process Simulation, V&V, Product Marketing, Hardware Diagnostics
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2007 — 2009
MBA, Business Development, Entrepreneurship
University of California, Los Angeles 1992 — 1997
Bachelors of Arts, History and a Specialization in Business Administration
Oticon Medical, LLC June 2015 - Present
Advanced Bionics February 2011 - February 2015
Advanced Bionics, LLC January 2010 - March 2011
Advanced Bionics May 2006 - January 2010
Skills
Medical Devices, Healthcare, Cross-functional Team..., Sales Management, Product Launch, Market Development, Surgeons, Team Building, Strategic Planning, Hospitals, Sales, Team Leadership, Sales Operations, ENT, Change Management, Quality System, Hardware Diagnostics, Clinical Research, Business Strategy, Business Planning, Budgets, Cochlear Implants, Recalls, HIPAA, Customer Service, Healthcare Reimbursement, Selling, CRM
Education
University of Northern Colorado 1999 — 2003
MA, Audiology
University of Northern Colorado 1998 — 2003
Master of Art, Audiology
Steamboat Springs High School 1991 — 1995
Advanced Bionics April 2013 - Present
Advanced Bionics LLC April 2012 - March 2013
Advanced Bionics LLC March 2005 - March 2012
Skills
Medical Devices, Clinical Trials, Healthcare, Clinical Development, Research
Education
Northwestern University 1978 — 1988
PhD, Physiology
Washington University in St. Louis 1972 — 1978
AB, MS, Biology, Audiology
Aspen High School
Advanced Bionics AG / Sonova Medical Division September 2012 - Present
Advanced Bionics, LLC April 2013 - Present
Advanced Bionics AG / Sonova Medical Division December 2011 - August 2012
Phonak Acoustic Implants SA / Sonova Medical Division February 2011 - November 2011
Phonak Communications AG January 2006 - January 2011
Phonak Communications AG January 2003 - December 2005
Phonak Communications AG June 2001 - December 2002
ETA SA / Swatch Group April 1999 - May 2001
Skills
Product Life Cycle..., General Management, R&D, Microelectronics, Medical Devices, Microtechnology, Wireless, Semiconductors, Photovoltaics, Renewable Energy, Solar, Embedded Systems, Telecommunications, MEMS, ASIC, Management, Signal Processing, Electronics, ISO 13485, Optics, Product Lifecycle..., Biomedical Engineering, Solar Energy, Product Management, IC, Hardware Diagnostics, Project Management, Product Launch, Manufacturing, Analog, Design of Experiments, Digital Signal..., Embedded Software, PCB design, Product Development, Sensors
Education
Ecole polytechnique fédérale de Lausanne / Institute of Microtechnology 1994 — 1999
Dr. sci.
Princeton University 1997 — 1998
Visiting Graduate Student
University of Stuttgart 1988 — 1993
Dipl.-Ing., Electrical Engineering
Management Centre Europe
Advanced Bionics LLC November 2010 - Present
Sulzer Pumps (US) Inc. May 2001 - August 2011
Sulzer International Ltd., Switzerland September 1999 - April 2001
Interroll April 1998 - August 1999
Lista AG, Erlen, Switzerland August 1994 - March 1998
Skills
Restructuring, Risk Management, Forecasting, Change Management, Mergers, Management, Business Planning, Finance, Strategic Planning, Process Improvement, Financial Reporting, Mergers & Acquisitions, Financial Modeling, Financial Analysis, Auditing, Cross-functional Team...
Education
Harvard Business School 2014 — 2014
Advanced Management Program (AMP 187), Leadership
The University of Chicago 2007 — 2008
Chicago Excecutive Institute, Leadership
Akademie, St. Gallen Fachhochschule 1998 — 2001
Certified Expert in Accounting Standards and Controlling, Accounting, Controlling
Akademie, St. Gallen Fachhochschule 1990 — 1993
Certified Accountant, Accounting
Boston Scientific April 2011 - Present
Advanced Bionics, LLC September 2006 - April 2011
Advanced Bionics September 2006 - May 2008
St. Jude Medical 2003 - 2006
Finisar 2002 - 2003
Sabeus 2001 - 2002
Alcatel-Lucent February 1994 - May 2001
Skills
Medical Devices, CAPA, ISO 13485, FDA, Quality System, V&V, Design Control, ISO 14971, Design of Experiments, Validation, FMEA, SPC, Failure Analysis, DMAIC, Quality Assurance, Root Cause Analysis, Six Sigma, R&D, Quality Control, Product Development, Design for Manufacturing, Supplier Quality, Injection Molding, ISO, 21 CFR, Cross-functional Team..., Manufacturing, Process Simulation, Lean Manufacturing, GMP, Iso 9000, 21 CFR Part 11, Minitab, Testing, Quality Auditing, Gage R&R, Manufacturing..., Biomedical Engineering, Quality Management, CE marking, CQE, Continuous Improvement, Reliability Engineering, Commercialization, Engineering Management, Process Capability, Medical Device R&D, Supplier Evaluation, FDA GMP, Risk Management
Education
University of California, Los Angeles 2014 — 2014
Biotechnology Engineering
Batangas State University 1985 — 1990
BSEE, Power Systems
Stanford University
Strategic Decision and Risk Management
California State University-Dominguez Hills
MSQA Program
Avita Medical July 2010 - Present
Advanced Bionics, LLC October 2005 - June 2010
SonaMed Corporation January 1995 - September 2005
Skills
Biomedical Engineering, Clinical Research, Medical Devices, FDA, Biotechnology, Lifesciences, R&D, Product Development, Tissue Engineering, Hospitals, ISO 13485, Product Launch, Medicine, Clinical Trials, Design Control, Clinical Development, Regulatory Affairs
Education
Boston University 1992 — 1995
MS, Biomedical Engineering
Boston University 1988 — 1992
BS, Biomedical Engineering
Intel Corporation March 2013 - Present
Advanced Bionics LLC July 2012 - March 2013
ILX Lightwave Corporation January 2008 - July 2012
Montana State University September 2003 - December 2007
ZTE Corporation July 2001 - September 2003
Skills
Embedded Systems, Digital Signal..., Firmware, FPGA, VHDL, Debugging, RTOS, PCB design, C, Algorithms, Matlab, C++, Electronics, Integrated Circuit..., Circuit Design, Microprocessors, I2C, Assembly Language, Wireless, Testing, Programming, USB, Labview, Signal Processing, Embedded Software, Digital Signal..., Verilog, ARM, Microcontrollers, Audio Processing, Simulations, SoC, SPI
Education
Montana State University-Bozeman 2003 — 2007
Ph.D., Electrical and Computer Engineering
Xiamen University 1998 — 2001
M.S., Electronics Engineering
Xiamen University 1994 — 1998
B.S., Electronics Engineering
Advanced Bionics AG April 2013 - Present
Advanced Bionics January 2011 - March 2013
Advanced Bionics LLC February 2010 - January 2011
Siemens Water Technologies January 2008 - January 2010
Siemens Audiologische Technik GmbH December 2003 - December 2007
Siemens Audiologische Technik GmbH May 2002 - November 2003
Siemens Medical Instruments Pte Ltd, Singapore April 1997 - April 2002
Siemens Medical Instrument Pte Ltd 1997 - 2002
Skills
Product Development, Manufacturing, Medical Devices, Management, Leadership, R&D, Product Launch, FDA, Operations Management, Supply Chain Management, Product Management, Cross-functional Team..., Start-ups
Education
University of Erlangen-Nuremberg 1982 — 1986
Dr. Ing., Institut fuer Hochfrequenztechnik
American Vision Windows June 2015 - Present
Baxter Medical Biosciences Division March 2012 - October 2014
Milgard Window September 2010 - February 2012
Advanced Bionics LLC April 2008 - September 2010
Advanced Bionics May 2005 - April 2008
Budget Blinds February 2000 - February 2005
Budget Blinds July 1996 - January 2000
Skills
Sales, Management, Start-ups, Environmental Awareness, Strategic Planning, Medical Devices, Recruiting, EHS, ISO 13485, Manufacturing, Training, ISO, Continuous Improvement, FDA, Quality System, Team Building, Root Cause Analysis, Quality Assurance, Lean Manufacturing, Solidworks
Education
Grand Valley State University 1988 — 1992
Occupational Safety and Health Management, Environmental Health and Safety Management
Advanced Bionics March 2011 - Present
Advanced Bionics, LLC October 1987 - May 2011
Skills
ISO 13485, Medical Devices, Design of Experiments, FDA, Electronics, Biomedical Engineering, V&V, Design Control, Quality System, Minitab, CAPA, ISO 14971, Hardware Diagnostics, R&D, Capital Equipment, Six Sigma, Manufacturing, Cross-functional Team..., Validation, Product Development, Commercialization, FMEA, Process Simulation, CE marking, Class III Medical..., 21 CFR
Education
UCLA
BSEE, Electronic Circuits
University of California, Los Angeles
Advanced Bionics, LLC ownerTotally Jazzed ProductionsJanuary 1995 - October 2002
Education
University of Illinois at Urbana-Champaign 1971 — 1973
no, business
Precor September 2014 - Present
Precor September 2012 - August 2014
Cardiac Science March 2011 - August 2012
Advanced Bionics May 2010 - February 2011
Advanced Bionics, LLC January 2006 - April 2010
Christ College 2001 - 2003
Skills
Business Intelligence, Troubleshooting, Medical Devices, Matlab, FDA, Testing, Training, Engineering
Education
Purdue University
M.S, Electrical and Computer Engineering
Saurashtra University - Rajkot, Gujarat
Post Graduate Diploma, Advanced Computer Applications
Gujarat University
B. E, Instrumentation and Control
Boston Scientific Neuromodulation April 2012 - Present
ADVANCED BIONICS LLC June 2008 - April 2012
Boston Scientific January 2004 - July 2008
Advanced Bionics, LLC 2000 - January 2004
Skills
Electronics, Engineering, Design of Experiments
Education
Los Angeles City College 1991 — 1995
AAE, ITT TECHNICAL INSTITUDE