Critikon Company
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Critikon Employees
E-Image Digital Studios, Inc. 1987 - Present
HeikeKnits.com October 2010 - Present
ASQ Section 1508 1986 - July 2011
Tampa's Lowry Park Zoo 2000 - 2009
American Society for Quality 1508 1999 - 2009
R.P. Scherer, Inc. 1980 - 1987
Critikon 1979 - 1980
International Medication Systems (IMS) 1976 - 1979
Skills
Event Management, Auditing, Strategic Planning, Quality Management, Customer Service, Quality Assurance, Microsoft Office, Problem Solving, Medical Devices, Budgets, Process Improvement, Continuous Improvement, Leadership Development, Team Building, Advertising, Event Planning, Contract Negotiation, Training, Leadership
Education
University of South Florida 1987 — 1996
BSc, Accounting
Oregon State University 1973 — 1976
BSc, Microbiology
Ridgewood High School
USPTO August 2012 - August 2013
SHA 2009 - 2011
Nimbus III July 2006 - December 2009
Communique Company January 1987 - December 2009
Critikon 1996 - 1998
Message Express 1987 - 1996
Tasnet 1990 - 1993
Wang Labs 1980 - 1986
Centronics 1977 - 1980
LFE corp 1977 - 1979
Skills
Telecommunications, modems, Tech writing, Product specification, Power and ground..., Software testing, electro optics, Agency compliance, Testing, Technical Writing, Modems, Project Management, Semiconductors, Systems Engineering, Electro-optics, Electronics, Program Management, Engineering Management, Integration, Engineering, Management
Education
pto academy 2012 — 2013
N/A, Patents
Rensselaer Polytechnic Institute 1967 — 1971
BSEE, MEE, Electrical Engineering, Computer science.
Gorton 1956 — 1960
Wilmont, LLC May 2012 - Present
Howell Custom Homes August 2003 - Present
Remy International 2001 - 2004
Critikon 1981 - 1984
Skills
Custom Homes, Construction, Contract Negotiation, Renovation, Contractors, Construction Management, Residential Homes, Real Estate, Negotiation, Product Development, Budgets, Sales, Land Development, Board of Director..., Purchasing, Procurement, Manufacturing, Process Scheduler, Managing Complex Sales, Green Building, Program Management
Education
Purdue University 1974 — 1978
BS MET, Engineering
Lapel High
Lockheed Martin PresidentApex Contractors2011 - 2013
Apex Contractors 2011 - 2013
Motorola 1998 - 2002
General Electric 1984 - 1996
Critikon 1986 - 1987
Skills
Electricians, Engineering Management, Design for Manufacturing, Systems Engineering, Electrical Engineering, PCB design, Testing, Electronics, Embedded Systems
Education
University of Massachusetts, Amherst 1984 — 1988
MSEE, Electrical and Electronics Engineering, 3.1
Union College 1981 — 1984
Bachelor of Science (BS), Electrical and Electronics Engineering
Hudson Valley Community College 1979 — 1981
Associate of Science (A.S.), Engineering
Mont Pleasant 1975 — 1979
GE Healthcare March 1999 - Present
GE Healthcare 2008 - 2012
GE Healthcare 1999 - 2008
GE Healthcare IT 1999 - 2008
Critikon 1999 - January 2001
Skills
Testing, Electromagnetic..., Medical Devices, Product Development, Leadership, EMC compliance, Six Sigma, Quality System, Electronics, FDA, FMEA, Design Control, R&D, Cross-functional Team..., Engineering Management, Engineering, Design for Manufacturing
Education
University of Wisconsin 2012 — 2014
BS Business Management, Organizational Leadership
ITT Technical Institute 1994 — 1996
ASEET, Electrical Engineering Technology
Embry-Riddle Aeronautical University 1989 — 1992
Magnetic Insight Inc May 2015 - Present
PerkinElmer - Life Science and Technology Division November 2011 - Present
Caliper Life Sciences a PerkinElmer Company March 2003 - Present
Xenogen Corporation March 2003 - August 2006
BioSpace, Inc. (an onTargetjobs Company) 2000 - 2003
WebMD 2000 - 2001
Cerner 1999 - 2000
Critikon 1995 - 1999
Skills
Biotechnology, Lifesciences, Strategy, Sales Management, Strategic Planning, Sales, Management, Sales Process, Medical Devices, Entrepreneurship, Pharmaceutical Industry, Mergers, Enterprise Software, Clinical Development, Commercialization, Product Development, Oncology, New Business Development, Cross-functional Team..., Product Marketing
Education
Iona College 2004 — 2007
MBA, Finance
Wright State University 1989 — 1993
BS Business Admin and Marketing, Marketing
Carroll High School 1984 — 1988
Medtronic July 2015 - Present
University of New Haven November 2013 - Present
Medtronic - Covidien Group May 2011 - Present
Covidien 2006 - May 2011
Covidien 2003 - 2006
US Surgical 1996 - 2003
US Surgical 1993 - 1996
Critikon 1982 - 1992
Personal Products 1981 - 1983
Skills
Six Sigma, Lean Manufacturing, SPC, DMAIC, Continuous Improvement, Black Belt, Cross-functional Team..., Process Improvement, Kaizen, Medical Devices, Minitab, Root Cause Analysis, FMEA, Operational Excellence, Systems Thinking, Business Process..., Analysis, Value Stream Mapping, 5S, Problem Solving, Team Building, Change Management, Coaching, Lean Sigma, Cost Reduction, Statistics, Team Leadership, Data Analysis, Excel, Organizational..., CAPA, Design of Experiments, Product Development, Microsoft Excel, Leadership, ISO 13485, Quality Management, Manufacturing..., FDA, V&V
Education
Capella University 2009 — 2013
Master of Business Administration (MBA)
University of Phoenix
BS/Business Mangement
Regulatory Compliance Associates Inc. June 2013 - Present
Regulatory Compliance Associates Inc. August 2009 - May 2013
Baxter 2005 - 2009
GE Healthcare 2001 - 2005
Critikon 1997 - 2001
Medtronic 1990 - 1997
Honeywell Aerospace 1985 - 1990
USAF 1981 - 1985
Skills
Medical Devices, Design Control, Leadership, Quality Assurance, Cross-functional Team..., Project Management, ISO 13485, Software Development, ISO 14971, Pharmaceutical Industry, Validation, Continuous Improvement, Program Management, CAPA, FDA, R&D, ISO, Process Improvement, Strategic Planning, Testing, Product Lifecycle..., FMEA, Manufacturing, Quality System, Embedded Systems, Quality Management, Team Leadership, GMP, Commercialization, Lean Manufacturing, Biotechnology, V&V, Engineering, Product Development, Six Sigma, Product Management, Regulatory Affairs, Operations Management, GLP, Process Engineering, Design for Manufacturing, Sop, Lifesciences, Change Control, Root Cause Analysis, DMAIC, Regulatory Submissions, Design of Experiments, Biomedical Engineering, Start-ups
Education
University of Minnesota - Carlson School of Management 1988 — 1991
MBA, Operations
University of Wisconsin-Superior 1977 — 1981
BS, math
Osseo-Fairchild High School 1974 — 1977
ConMed Linvatec September 2008 - Present
GE Healthcare December 1997 - September 2008
Critikon December 1997 - September 2008
Private Consulting 1996 - 2006
Baxter Healthcare May 1992 - November 1998
Sperry Microwave May 1985 - June 1991
Skills
Medical Devices, Six Sigma, R&D, Product Development, ISO 13485, Design Control, Cross-functional Team..., FDA
Education
University of South Florida 2013 — 2015
Master of Science (M.S.), Engineering Management
University of South Florida 1987 — 1991
BS, Electrical Engineering
GE Healthcare - IT 2001 - Present
GE Healthcare March 1992 - Present
Critikon 1993 - 1999
Johnson & Johnson -- Critikon, Inc. 1992 - 1999
Critikon, a Johnson & Johnson Company 1992 - 1999
SpaceLabs 1990 - 1992
Skills
Design Control, Medical Devices, FDA, Quality System, R&D, Validation, FDA GMP, Healthcare Information..., Six Sigma, Product Development
Education
University of Alabama at Birmingham 1978 — 1982
MS Engineering, Biomedical Engineering
REU Associates Inc. September 2001 - Present
STERIS Corporation September 1996 - September 2001
Johnson & Johnson May 1977 - June 1995
Critikon 1986 - 1989
Critikon, a Johnson & Johnson Company 1986 - 1989
Skills
Medical Devices, FDA, ISO 13485, Quality System, Regulatory Affairs, Design Control, CAPA, V&V, Validation, GMP, Biotechnology, Pharmaceutical Industry, Manufacturing, Quality Assurance, 21 CFR Part 11
Education
Cleveland State University
Philips Mostly Software GuyCritikon / Johnson & Johnson1983 - 1994
Critikon 1981 - 1994
Johnson & Johnson (division separated to become Critikon) 1981 - 1994
Johnson & Johnson 1981 - 1993
Education
Cornell University
BSEE
MGN Promotions, Inc. February 1995 - Present
Critikon Johnson & Johnson September 1980 - August 1994
Critikon 1980 - 1994
Education
Nova Southeastern University 1989 — 1992
bs, business
Kimberly-Clark August 1998 - Present
Critikon 1994 - 1998
Skills
Medical Devices, Skills: Capital..., Healthcare, Sales, Business Strategy, Sales Operations, Marketing Strategy, Management, Sales Management, Competitive Analysis, Cross-functional Team..., Key Account Management, Account Management, Product Launch, Capital Equipment
Education
California State University-Long Beach 1986 — 1989
Business Administration, Finance
California State University-Long Beach 1985 — 1989
Edwards Lifesciences Sr. Director, Regulatory AffairsEdwards Lifesciences2002 - 2014
Edwards Lifesciences 2002 - 2013
Critikon 1977 - 1980
Skills
FDA, ISO 14971, Design Control, PMA, Medical Devices, Regulatory Affairs, CAPA, ISO 13485, Regulatory Submissions, CE marking, Regulatory Requirements, CTMS, Cross-functional Team..., GMP
Education
University of California, Irvine 1973 — 1978
Biological Sciences, Biology, General
Domain Surgical, Inc. August 2010 - Present
Zevex January 2005 - August 2010
CardioNet July 2000 - June 2004
Alaris Medical Systems July 1991 - July 2000
Critikon 1984 - 1991
Skills
Design for Manufacturing, Medical Devices, Injection Molding, ISO 13485, FDA, Manufacturing, SPC, ISO 14971, Start-ups, Design Control, Cross-functional Team..., Product Development, Manufacturing..., Quality System, Six Sigma, ISO, Continuous Improvement, R&D, Product Design, Systems Engineering, Validation
Education
Santa Clara University - Leavey School of Business 1987 — 1990
MBA
University of Colorado at Boulder 1974 — 1978
BA Physics, Physics, Molecular Biology