Symphonix Devices
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Symphonix Devices Employees
B2C Solutions 2012 - Present
NutriGems Essentials November 2014 - Present
Nutrigenomics and Nutritional Epigenetics April 2006 - Present
Freelance July 2006 - Present
TLR Tech Ltd. January 2008 - May 2014
Extended Care October 2006 - May 2013
Rambam Health Care Campus October 2005 - October 2006
Guidant Corporation June 2001 - August 2004
Symphonix Devices May 2000 - June 2001
Kaiser Permanente October 1998 - May 2000
Skills
Nutrition, Nutrigenomics, Epigenetics, Clinical Research, Medicine, Nutritional Counseling, Nutrition Education, Wellness, Research, FDA, Science, Sports Nutrition, Diabetes, English, Healthcare, Public Health, Health Education, Teaching, Public Speaking, Microsoft Office, Mac OS
Education
Case Western Reserve University School of Medicine 1994 — 1995
Master of Science (MS), Clinical Nutrition/Nutritionist
University of California, Santa Cruz 2000 — 2001
Clinical Nutrition Manager, Clinical Research Management, Certification
San Jose State University 1989 — 1993
Bachelor of Science (BS), Clinical Nutrition/Nutritionist
Portescap July 2014 - Present
Kaleidoscope March 2014 - June 2014
LifeScan September 2012 - February 2014
Ethicon Endo-Surgery November 2003 - September 2012
Ethicon, Inc 2001 - 2003
SURx 1998 - 2001
Symphonix Devices 1994 - 1998
ACS, Guidant 1989 - 1994
I-Stat Corporation 1984 - 1989
Skills
Design Control, Medical Devices, Medical Device Product..., MRI, Lifesciences, ISO 13485, Biomedical Engineering, Product Development, FDA, Design of Experiments, R&D, SPC, CAPA, FMEA, Root Cause Analysis, Engineering, Finite Element Analysis, Manufacturing, Design for Manufacturing, V&V, ISO 14971, Minitab, Quality System, Injection Molding, Process Engineering, Product Launch, DMAIC, Validation, Surgical Instruments, Medical Device R&D, Biomaterials, Failure Analysis
Education
University of Pennsylvania 1976 — 1984
BA, BSEE, MSEE, Electrical Engineering and Natural Sciences
Illumina January 2015 - Present
Illumina July 2013 - December 2014
SynteractHCR, Inc. October 2007 - June 2013
Synteract, Inc. June 2006 - October 2007
Elan Pharmaceuticals 2006 - 2006
Clinimetrics 2002 - 2004
Symphonix Devices 2001 - 2002
Genentech 1998 - 2000
Skills
Clinical Trial..., GCP, Clinical Monitoring, Clinical Research, Clinical Trials, CTMS, CRO, Oncology, Pharmaceutics, Biotechnology, Medical Devices, Project Management, Clinical Development, Strategic Planning, Project Planning, Risk Management, Budget Forecasts, Budget Monitoring, Business Strategy, Business Development, Team Leadership, Team Mentoring, Data Management, EDC, Statistical Data..., Regulatory Submissions, ICH-GCP, 21 CFR, Client Relations Skills, Infectious Diseases, Cardiovascular Disease, Clinical Operations, Clinical Study Design, Drug Development, Pharmaceutical Industry, FDA, Life Sciences, SOP, Clinical Data Management, Management, 21 CFR Part 11, Biopharmaceuticals, Therapeutic Areas
Education
University of California, Santa Cruz 2000 — 2002
Certificate of Clinical Trials Design & Management
University of Oklahoma 1993 — 1998
B.S., Microbiology / Chemistry
ASQ March 2010 - Present
ASQ February 2009 - Present
Consultant - Quality Management and Engineering 1992 - Present
IntegenX January 2012 - April 2013
ArKal Medical April 2009 - September 2011
Oraya Therapeutics March 2007 - March 2009
Covidien June 2005 - March 2007
Abbott Diabetes Care June 2001 - June 2005
Therasense June 2001 - June 2005
Symphonix Devices June 1999 - June 2001
Skills
Design Control, ISO 13485, FDA, Medical Devices, Supplier Quality, CQA, Validation, CAPA, ISO, SPC, FMEA, Quality Assurance, APQP, Regulatory Affairs, Quality Management, Six Sigma, Root Cause Analysis, Lean Manufacturing, Continuous Improvement, Product Development, CQE, Auditing, Software Quality..., Kaizen, Process Improvement, Compliance, Quality Auditing, Risk Management, ISO 14971, QFD, PMA, V&V, Program Management, Biotechnology, Change Management, Quality System, Testing, Process Simulation, Software Documentation, Quality Control, Supply Management, Cross-functional Team..., GMP, R&D, Manufacturing, Process Engineering, Iso 9000, DMAIC, Engineering, Change Control
Education
University of California, Berkeley 1994 — 1996
University of Michigan-Dearborn 1990 — 1992
Michigan State University 1978 — 1981
St. Edward High School (Lakewood, Ohio) 1974 — 1978
SK hynix March 2015 - Present
Semtech Corp February 2012 - Present
IDT February 2009 - February 2012
Silicon Clocks September 2006 - February 2009
Amalfi Semiconductor June 2003 - September 2006
TDK Semiconductor March 1998 - August 2003
Symphonix Devices February 1995 - March 1998
Skills
Mixed Signal, PLL, Circuit Design, IC, Power Management, MEMS, Analog, EDA, Analog Circuit Design, Product Development, Semiconductors, Wireless, SERDES, Timing
Education
New Jersey Institute of Technology
MSEE, Electronics
Philips Medical Systems March 2008 - April 2015
RSA The Security Division of EMC January 2007 - January 2008
Maxtor October 2001 - August 2007
Symphonix Devices June 2000 - October 2001
IBM March 1997 - June 2000
Skills
R&D, Medical Devices, FDA, Program Management, Cross-functional Team..., Product Development, Manufacturing, Continuous Improvement, Embedded Systems, Product Management, Six Sigma, ISO 13485, Testing, Quality System, Medical Imaging, Embedded Software, Engineering Management, Electronics, Design Control, Engineering, Semiconductors, Validation, Project Management, Process Improvement, Leadership, Design for Manufacturing, Product Launch, Root Cause Analysis, Design of Experiments, Quality Assurance, Strategy, Biomedical Engineering, FMEA, SPC, Simulations, Software Engineering, Lean Manufacturing, Quality Management
Education
City University of New York City College 1992 — 1996
BSEE, Electrical and Electronics Engineering
Ironclad Performance Wear November 2001 - Present
Symphonix Devices 1995 - 2001
Guidant 1994 - 1995
Alfred Mann Foundation for Scientific Research 1989 - 1994
Skills
Product Development, Product Design, Start-ups, Product Management, Strategic Planning, Business Development, Entrepreneurship, Marketing Strategy, Marketing, ISO 13485, R&D, New Business Development, Medical Devices, Team Building, Biomedical Engineering
Education
University of California, Los Angeles 1985 — 1990
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Stryker Spine, formerly CoAlign Innovations February 2013 - November 2014
Maquet Cardiovascular November 2008 - February 2013
Maquet Cardiovascular (formerly Boston Scientific Cardiac Surgery Division) 2008 - February 2013
Biomerix 2007 - 2008
Boston Scientific December 2001 - November 2007
Symphonix Devices 1999 - 2001
GN ReSound A/S 1997 - 1999
Abbott Diagnostics 1994 - 1998
Skills
Lean Manufacturing, Process Validation, FMEA, FDA, Diagnostics, Medical Devices, ISO 13485, CAPA, Product Development, Design Control, Validation, Process Development, Project Management, V&V, Quality System, Engineering, Process Simulation, Biomedical Engineering, Injection Molding, R&D, ISO 14971, Design of Experiments, Minitab, Hardware Diagnostics, Manufacturing
Education
California Polytechnic State University-San Luis Obispo 1983 — 1986
Bachelor of Science (BS), Mechanical Engineering
Northeastern University 1965 — 1970
BA, History
Medtronic AF Solutions August 2010 - Present
Duane E. Tumlinson May 2006 - August 2010
Cameron Health May 2002 - May 2006
Symphonix Devices July 1996 - May 2002
Intermedics, Inc. May 1989 - July 1996
Skills
Design Control, ISO 13485, Mechanical Engineering, FDA, Biomedical Engineering, Design for Manufacturing, R&D, Design of Experiments, V&V, FMEA, Quality System, Cross-functional Team..., Product Development, Manufacturing, Engineering Management
Education
Northern Arizona University 1980 — 1983
BS, Mechanical Engineering
Abbott Medical Optics May 2013 - Present
Abbott Medical Optics 2011 - 2013
Abbott Diagnostics 2009 - 2011
Abbott / Hospira 2003 - 2006
Symphonix Devices 2000 - 2002
Abbott 1989 - 2000
Skills
Quality System, Project Management, Six Sigma, Quality Assurance, GAMP, Pharmaceutical Industry, Continuous Improvement, Manufacturing, Biotechnology, Strategy, Cross-functional Team..., Advisory Boards, Process Improvement, V&V, R&D, ISO 13485, GMP, Medical Devices, FDA, Design Control, Root Cause Analysis, Product Launch, Design of Experiments, CAPA, Change Control, Validation, Lean Manufacturing, 5S, Commercialization, Quality Management, Regulatory Affairs, Sop, ISO, Aseptic Processing, Quality Auditing, DMAIC, SPC, 21 CFR Part 11, Kaizen, FMEA, Manufacturing...
Education
Texas Tech University
Bachelor of Science (BS), Mechanical Engineering
The University of Dallas
Master of Business Administration (MBA), Engineering Management
AccessClosure, Inc. (a Cardinal Health Company) August 2007 - Present
CryoVascular Systems (acquired by Boston Scientific) 2001 - 2007
Symphonix Devices 2000 - 2001
CardioThoracic Systems (acquired by Guidant) 1999 - 2000
Ventritex (acquired by St. Jude Medical) 1991 - 1999
Skills
ISO 13485, Quality System, Materials, Medical Devices, ISO, Capital Equipment, FDA, Manufacturing, Cross-functional Team..., Validation, CAPA, V&V, Design Control, Product Launch, Product Development, R&D
Education
California State University-East Bay
B.A., Sociology