Telectronics Company
Industry: Company
DescriptionTelectronics Pty Ltd was an Australian company best known for its role in developing the pacemaker. It was located in Lane Cove, Sydney. In 1988 the business was acquired by Pacific Dunlop. Founder: Geoffrey Wickham
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Telectronics Employees
Experiencing Life (at a slower pace) February 2014 - Present
BEURER North America LP October 2012 - February 2014
Arthrex January 2009 - August 2009
Cordis February 1994 - December 2008
Telectronics February 1992 - February 1995
Skills
Design Control, CAPA, FDA, Medical Devices, ISO 13485, Quality System, FMEA, Minitab, GMP, V&V, ISO 14971, Design of Experiments, Biomedical Engineering, Validation, DMAIC, SPC, Design for Manufacturing, Manufacturing..., Gage R&R, Quality Assurance, Manufacturing, Failure Analysis, Product Development, Product Launch, Six Sigma, Injection Molding, Supplier Quality, Quality Control, ISO, Quality Management, Quality Auditing, Root Cause Analysis, Change Control, CQA, Lean Manufacturing, 21 CFR Part 11, FDA GMP, Iso 9000, 5S, Process Simulation, R&D, Value Stream Mapping, Continuous Improvement, Sop, 21 CFR, Catheters, GxP, QAQC, Aseptic Processing
Education
Florida International University 2002 — 2003
Masters, Engineering Management
University of Illinois at Chicago 1979 — 1983
BS, Mechanical Engineering
Odyssey Technical Solutions 2014 - Present
Media Dimensions, Inc 2007 - Present
Advanced Energy Industries 2008 - 2013
Quantum Corp October 2001 - March 2007
Quantum Inc 2001 - 2007
Exabyte 1998 - 2001
Telectronics January 1995 - January 1998
Skills
Engineering Management, Product Development, Program Management, Electronics, Engineering, Manufacturing, Semiconductors, Lean Manufacturing, Testing, Product Management, Cross-functional Team..., Six Sigma, PCB design, SPC, Power Supplies, Continuous Improvement, Design for Manufacturing, Design of Experiments, Quality System, RF, Analog, FMEA, Product Lifecycle..., Power Electronics, Root Cause Analysis, Automation, Failure Analysis, Electrical Engineering, R&D, Systems Engineering, Test Engineering, Test Equipment, Analog Circuit Design, Firmware, Labview, Simulations, Embedded Systems, Hardware Architecture, Circuit Design, Semiconductor Industry, Debugging, Embedded Software, FPGA, IC, Microcontrollers, Schematic Capture, Digital Signal..., Product Engineering, Hardware, Mixed Signal
Education
California Polytechnic State University-San Luis Obispo 1968 — 1972
BSEL, Electrical and Electronics Engineering
Sogeti August 2012 - Present
MiTek Industries January 2011 - August 2012
Rivet Software 2010 - 2010
The Library Corporation September 2001 - June 2007
Quark April 2000 - September 2001
The Library Corporation April 1997 - April 2000
Telectronics November 1996 - March 1997
Northwest Farm Credit Services October 1986 - October 1996
Skills
C#, T-SQL, C++, XML, OOP, ASP.NET, UML, Microsoft SQL Server, ASP.NET MVC, REST, JSON, Oracle, Architectural Patterns, WPF, WinForms, RPC, TFS, Scrum, Agile Methodologies, Web Services, OOAD, Rally, Fiddler, Database Modeling, NUnit, Moq, IIS, Code Collaborator, Visual Studio, Unit Testing, HTML 5, Software Development, Web Applications, .NET, Database Design, Java, SDLC
Education
University of Denver 2011 — 2012
Geographic Information Systems
Washington State University 1992 — 1993
Engineering Management
Eastern Washington University 1980 — 1985
B.S., Computer Science
St. Jude Medical May 1997 - Present
Ventritex November 1992 - May 1997
Telectronics April 1986 - November 1992
Skills
Cardiology, Capital Equipment, Pacemakers, Operating Room, Medical Devices, Interventional..., Surgeons, Disposables
Education
Purdue University 1979 — 1983
Biomedical/Medical Engineering
Clemson University 1978 — 1979
Medical Support Solutions, a Div. of FCVT, LLC May 2013 - Present
The Wilson Center May 2009 - January 2014
Murphy Leadership, Inc. June 2010 - April 2013
Intuitek April 2009 - June 2010
Florida Cardiovascular Technologies, LLC July 2006 - April 2009
CryoLife, Inc. 1998 - 2006
CryoLife, Inc. May 1986 - March 1998
Tri-Star Medical, Inc. October 1984 - April 1986
Graphic Controls September 1979 - October 1984
Telectronics June 1976 - July 1979
Skills
Change Management, Sales Management, Clinical Device..., CRM, Consulting, Leadership, Global Marketing, Strategy, Training, International Business..., Management, Staff Development, Solution Selling, Professional Services, Channel, Business Expansion, Group Dynamics, Product Introduction, Entrepreneurship, Cross-functional Team..., Business Development, Start-ups, Strategic Partnerships, Strategic Planning, Healthcare, Process Improvement, Medical Devices, Team Building, New Business Development, Sales, Product Development, Marketing, Leadership Development, Sales Operations, Organizational..., Executive Coaching, Selling, Business Strategy, Business Planning, Program Management, Negotiation, Product Management, Mergers & Acquisitions, Business Process..., Competitive Analysis, Performance Improvement, Outsourcing, Employee Training, Product Launch, P&L Management
Education
University at Buffalo 1975 — 1976
MSEE, Electrical Engineering, 3.5
University at Buffalo 1969 — 1972
BSEE, Electrical Engineering, 2.85
State University of New York College at Brockport 1964 — 1968
BS, Education, Seconday Math and Physics, 2.85
Lancaster Central Scholls 1959 — 1964
Regents Diploma, Math and Science, 88% New York State Regents Diploma
Noble Investments, LLC June 2012 - Present
Independent December 2011 - Present
ProtoTest August 2009 - December 2011
ProtoTest August 2004 - July 2009
Thomson Healthcare 2002 - 2004
Thomson - Micromedex 2000 - 2002
Micromedex 1998 - 2000
Micromedex 1996 - 2000
Telectronics 1991 - 1996
Texas Instruments 1987 - 1991
Skills
Quality Assurance, Change Management, Business Process, Customer Relations, SDLC, Business Systems, Process Improvement, Program Management, Business Analysis, Testing, Strategic Planning, Product Management, Cross-functional Team..., Vendor Management, Contract Negotiation, Business Strategy, Budgeting, Management Consulting, Microsoft Office, P&L Management
Education
University of Colorado 1982 — 1986
BS, Computer Science
DiVaccaro Consulting Group, LLC December 2013 - Present
DePuy J&J September 2005 - December 2013
DePuy a Johnson and Johnson Company September 2005 - June 2012
sanofi-aventis September 2000 - September 2005
Johnson & Johnson - Cordis October 1998 - September 2000
Telectronics January 1994 - July 1996
Baxter Diagnostics 1991 - 1993
Skills
Risk Assessment, ISO 11607, Auditing, 6-Sigma Black Belt..., Packaging Engineering, ISO, Six Sigma, Team Leadership, Design Control, Medical Devices, Quality System, Packaging, FDA, FMEA, Product Development, Validation, GMP, Sterilization, Engineering, Lean Manufacturing, Manufacturing, Design of Experiments, Project Management, Continuous Improvement, Plastics, ISO 13485, CAPA, R&D, Root Cause Analysis, Minitab, SPC
Education
Michigan State University 2001 — 2005
MS, Packaging
Michigan State University 1985 — 1989
BS, Packaging
Alma College 1984 — 1985
Mechanical Engineering
St. Mary's Cathedral 1980 — 1984
Pre-College
Nebraska Furniture Mart, Inc July 1996 - Present
Pete Ricketts for Governor of Nebraska April 2013 - November 2014
Jeppesen Sanderson September 1988 - February 1996
Colorado For Nebraska Alumini Association Board of Directors June 1988 - March 1995
Telectronics June 1987 - September 1988
Translogic Corporation January 1986 - April 1987
Skills
Forecasting, Financial Reporting, Financial Accounting, Accounting, Cost Accounting, Auditing, Consolidation, Microsoft Excel, Management, Financial Statements, Finance, Team Leadership, Variance Analysis, Account Reconciliation, Strategic Planning, Financial Analysis, Pricing
Education
University of Nebraska-Lincoln 1980 — 1984
B.S. in Business Administration, Accounting, 3.8
Lincoln School of Commerce 1977 — 1978
Associates, Business
The Juice Plus+ Company July 2013 - Present
Sedgwick January 2013 - June 2013
Synchron Technology May 2012 - December 2012
TEK Systems August 2011 - May 2012
JJensen Designs May 2011 - August 2011
Hilton Worldwide May 2010 - May 2011
Hilton Hotels October 2002 - May 2010
TBC Corporation March 1999 - October 2002
Telectronics January 1995 - March 1997
Skills
VB.NET, Java, JavaScript, CScript, SQL Server, XML, SQL, Software Development, HTML, Microsoft SQL Server, SDLC, Windows Server
Education
Western Governors University 2013 — 2017
Bachelor of Science (BS), Computer Science
The University of Memphis 2009 — 2011
Information Technology, 3.8
Southwest Tennessee Community College 2004 — 2005
General
Hawaii Institute of Electronics 1985 — 1986
Technical, Electronics
Physio-Control, Inc. 2011 - Present
Boston Scientific 2010 - January 2011
Boston Scientific 2007 - 2010
Guidant 2005 - 2007
Guidant 1998 - 2005
Incontrol, Inc 1997 - 1998
Telectronics 1995 - 1997
Orthomet 1992 - 1995
Skills
FDA, Quality System, ISO 13485, GMP, Validation, Software Development, Medical Devices, Quality Assurance, V&V, Design Control, ISO 14971, Testing, Systems Engineering, Embedded Systems, Cross-functional Team..., R&D, Biomedical Engineering, Regulatory Affairs, CAPA, Design of Experiments, Computer System...
Education
University of Minnesota-Twin Cities 1974 — 1980
BS, Education
MDM Engineering Consultants August 2009 - Present
Baxter Healthcare 2005 - August 2009
Baxter Healthcare 2003 - 2005
Baxter Healthcare 2000 - 2003
Althin Medical July 1997 - March 2000
Telectronics January 1987 - May 1997
Cordis March 1984 - June 1987
Skills
FDA, Requirements Management, Risk Management, Medical Devices, FMEA, CQA, ISO, Process Validation, Design Control, Quality Systems, Validation, Quality Engineering, Software Validation, Quality Auditing, ISO 14971, QSR, Computer System..., ISO 13485, DMAIC, Change Control, Root Cause Analysis, Quality Management, Software Quality, 21 CFR Part 11, Continuous Improvement, Product Life Cycle..., Doors, Systems Engineering, Process Improvement, Assurance Cases, Iso 9000, Quality System, Testing, V&V, Quality Control, GMP, Quality Assurance, R&D, Product Lifecycle..., Engineering, Manufacturing, CAPA, Design of Experiments, Lean Manufacturing, Sop, Software Documentation, Biomedical Engineering, SDLC, Six Sigma, Process Engineering
Education
University of Miami 1980 — 1984
BSEE, Electrical Engineering
May International Productions Secretary of the BoardCentro Mater Daycare and Neighborhood CenterSeptember 1990 - Present
Telectronics 1987 - 1990
Cordis 1983 - 1987
Education
University of Miami 1981 — 1983
MBA, Finance
University of Miami 1977 — 1981
BBA, International Finance and Marketing
Respicardia May 2013 - Present
Cameron Health, Inc February 2007 - April 2013
Boston Scientific August 2003 - February 2007
Eli Lilly June 2002 - August 2003
Guidant January 1997 - June 2002
Telectronics 1995 - 1997
Skills
Medical Devices, Clinical Research, FDA, Healthcare, Biomedical Engineering, Clinical Trials, Electrophysiology, CTMS, CRO, Design Control, Cardiology, Product Launch, Heart Failure, Pacemakers, ISO 13485, Start-ups, Clinical Development, Protocol, Biotechnology, Surgery, Medical Imaging, Commercialization, Capital Equipment, Hardware Diagnostics, GCP, Regulatory Affairs, CAPA, Validation
Education
Ball State University 1987 — 1992
BS, Physiology
Nancy January 1999 - Present
Telectronics July 1985 - June 1995
Television Technology Corporation June 1982 - June 1985
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, English, Windows, Photoshop
Education
Community College of Denver 1969 — 1971
1 year, Computer Programming
Community College Business Management
Associate's degree, Computer Science
Self employed May 2010 - Present
BIOTRONIK February 1998 - Present
Gambro Renal Products February 1997 - January 1998
Telectronics May 1989 - January 1997
Northern Telecom September 1988 - May 1989
Emco Electronics August 1986 - July 1988
Texas Instruments June 1983 - June 1986
Gulf States Utilities June 1979 - May 1982
Skills
Photography
Education
North Carolina State University 1987 — 1989
MS, Computer Engineering
Lamar University 1978 — 1983
Bachelors, Electrical Engineering
Medtronic August 2012 - Present
Johnson & Johnson November 2010 - July 2012
Johnson & Johnson January 2010 - October 2010
Ethicon 2005 - 2010
Cordis 1997 - 2005
Cordis, Johnson & Johnson 1997 - 2005
Telectronics 1994 - 1997
Skills
Medical Devices, Marketing Strategy, Marketing Management, Pricing Strategy, Regulatory Affairs, Strategic Planning, Wound Care, Commercialization, Global Marketing, Market Development, Competitive Analysis, International Business, Product Launch, Brand Management, FDA, Strategy, Product Development, Product Marketing, Cross-functional Team...
Education
University of South Carolina - Darla Moore School of Business 1992 — 1994
MBA, International Business
Dartmouth College 1985 — 1989
BS, History
Phiston Technologies July 2014 - Present
Engineering Contractor August 2012 - July 2014
Safestitch Medical November 2011 - August 2012
Beckman Coulter January 2002 - November 2011
Beckman Coulter January 1995 - January 2002
Cordis January 1993 - January 1995
Baxter International Inc. January 1992 - January 1993
Baxter International Inc. January 1990 - January 1992
Telectronics January 1989 - January 1990
Cordis January 1987 - January 1989
Skills
ISO 13485, Design Control, Solidworks, R&D, Medical Devices, FDA, Manufacturing, Six Sigma, Engineering, Product Development, Continuous Improvement, Lean Manufacturing, Design for Manufacturing, Cross-functional Team..., Product Design, Mechanical Engineering, CAD, Validation, Testing, ISO, SolidWorks
Education
Florida International University 1983 — 1987
Bachelor of Science (B.S.), College of Mechanical Engineering
Florida International University - College of Business Administration
Advanced Project Management
Florida International University - College of Business Administration
Supervisory Certificate Program
Orange Theory Fitness 2015 - Present
St. Jude Medical July 2010 - July 2015
Evergreen L.A.N.D. October 2006 - July 2010
Medtronic April 1995 - October 2006
Telectronics December 1992 - July 1995
Skills
Strategic Planning, Marketing Strategy, Business Development, Growth Strategies, Professional Experience, Integrity, Humor, Management, Consulting, Biotechnology, Brand Development, Medical Devices, Sales, Product Launch, CRM, Market Development, Capital Equipment, Cardiology, Sales Operations, Operating Room, Sales Management
Education
Florida International University 1985 — 1990
Bachelor of Arts (BA), Psychology
UTHSCSA 2007 - Present
Raise Your Hand Texas 2007 - Present
NEISD 2008 - 2010
Sulzer Intermedics, Inc. 1993 - 1998
Telectronics 1989 - 1993
Humana Hospital 1987 - 1989
Skills
Public Speaking, Strategic Planning, Customer Relations, Marketing Strategy, Marketing Communications, Fundraising, Sales, Customer Service, Marketing, Social Media, Negotiation, Leadership, Management, Team Building, Training
Education
St. Mary's University 1985 — 1987
MBA, Marketing and Finance
The University of Texas at Austin
BA, Art History
RSVB Consulting, Inc. November 2012 - Present
Teva Pharmaceuticals 2013 - 2013
Teva Pharmaceuticals 2013 - 2013
Aveva Drug Delivery Systems, Inc. February 2008 - October 2012
Image Solutions, Inc. (ISI) 2007 - 2008
Kos Pharmaceuticals 1992 - 2007
Telectronics 1986 - 1992
Key Pharmaceuticals 1982 - 1986
Skills
Regulatory Affairs, FDA, Pharmaceutical Industry, GMP, CAPA, Regulatory Submissions, Sop, eCTD, Validation, IND, Clinical Development, Biotechnology, Regulatory Requirements, Drug Development, 21 CFR Part 11, GCP, Clinical Trials, GxP, GLP, Quality System, Pharmacovigilance, Medical Writing, Biopharmaceuticals, Medical Devices, Quality Auditing, Regulatory Documentation, Change Control
Education
Salisbury University
BS, Biology
aPriori Technologies October 2013 - Present
BAE Systems August 2008 - October 2013
WR Grace August 2004 - August 2008
HELIX TECHNOLOGY CORP, CTI – MANSFIELD, MA August 1999 - August 2004
Ford Motor Company 1988 - 1999
Telectronics 1994 - 1998
Skills
Systems Engineering, Defence, DoD, Security Clearance, Earned Value Management, Aerospace, Military, Air Force, Secret, Lean Manufacturing, Program Management, Manufacturing, Root Cause Analysis, Project Management
Education
ULowell 1988 — 1992
Bachelor of Science (B.S.), Mechanical Engineering
University of Maine 1981 — 1985
B.S., Business, Management, Marketing, and Related Support Services
EY July 2015 - Present
Temple University September 2014 - June 2015
salesforce.com May 2014 - August 2014
Temple University June 2012 - August 2013
MESA TECHNOLOGY INC February 2013 - May 2013
Temple University May 2012 - July 2012
Intensive English Language Program at Temple University May 2011 - December 2011
Telectronics September 2010 - December 2010
Skills
MySQL, SAP, Salesforce.com, Google Sites, WordPress, Symantec Endpoint..., NeXpose, Microsoft Project, Microsoft Excel, PowerPoint, Microsoft Office, Public Speaking, Access, Social Media, Customer Service, Teamwork, Information Technology, Windows Server, Linux Server, ACLS, Management, Time Management, Leadership, Project Management
Education
Temple University 2014 — 2015
Master of Science (M.S.), Information Technology & Cyber Security, 3.67
Temple University 2010 — 2013
BBA, Management Information Systems & Finance, 3.61
Lutheran Family Services of Colorado July 2008 - Present
Back Talk Systems, Inc 2003 - 2008
Global Healthcare Exchange April 2000 - August 2002
Thomson Micromedex May 1997 - June 1998
Telectronics 1991 - 1997
Skills
Non-profits, Event Planning, Social Media, Marketing Communications, Editing, Public Relations, Email Marketing, Public Speaking, Copywriting, Social Media Marketing, Marketing, Event Management, Fundraising, Strategic Planning, Research, Project Planning, Nonprofits, Marketing Strategy, Program Development
Education
Art Institute of Colorado
Associate's degree, Advertising Design
University of Colorado at Denver
Bachelor of Sciene - Business Administration, Marketing
Qualified Data Systems August 2001 - Present
BearingPoint 2001 - 2002
KPMG Consulting 1998 - 2001
Beckman Coulter 1996 - 1998
Telectronics 1994 - 1996
Baxter Healthcare 1988 - 1994
Skills
Leadership, Medical Device Product..., Medical Device Software, Enterprise Risk..., IT Strategy, Telehealth, Test Engineering, EAI, Quality Assurance, Medical Software, Medical Devices, Integration, Mergers
Education
Florida International University
BSEE, Electrical Engineering, Computer Engineering, Bio-Medical Engineering, Applied Statistics
Medical Device Technologies, Biotronik March 2008 - Present
BIOTRONIK August 1997 - March 2008
Telectronics 1993 - 1997
Skills
Medical Devices, Hospitals, Clinical Research, Critical Care, Electrophysiology, Operating Room, Program Management, Capital Equipment, Surgeons, Biomedical Engineering, Healthcare
Education
Texas Woman's University 1968 — 1972
Bachelor of Science (BS), Nursing
Texas Woman's University College of Nursing 1968 — 1972
BSN
WinansTech March 2005 - Present
iCAD, Inc. August 2005 - March 2006
iCAD, Inc. August 2000 - October 2003
Ortho Clinical Diagnostics August 1998 - May 1999
Telectronics December 1985 - June 1997
Skills
R&D, Testing, Quality Assurance, FDA, Medical Devices, V&V, PHP, Product Development, MySQL, SQL, Cross-functional Team...
Education
University of Colorado Denver 1979 — 1984
BSEE (incomplete), Electrical Engineering
Craig Clinical and Regulatory Consulting, LLC March 2015 - Present
Biodesix, Inc. August 2009 - March 2015
ARCA biopharma, Inc. March 2009 - July 2009
Gilead Sciences/ Myogen Inc. (acquired by Gilead Sciences) September 2004 - March 2009
Allos Therapeutics May 1998 - September 2004
XOMA Corporation November 1996 - April 1998
Telectronics March 1995 - November 1996
Sulzermedica March 1990 - March 1995
Skills
Biotechnology, Clinical Trials, Life Sciences, Oncology, Pharmaceuticals, Program Management, Clinical Operations, Clinical Diagnostics, Cardiovascular Medicine, Regulatory Affairs, Regulatory Reporting, NDA, Clinical Development, Clinical Research
Education
University of Kansas
BS, Human Biology
Olathe Medical Center June 2013 - Present
The University of Kansas Hospital Authority 2006 - June 2013
The University of Kansas Hospital Authority 2005 - 2006
The University of Kansas Hospital Authority 1999 - 2005
Kaiser Foundation Health Plan 1998 - 1999
CIGNA Healthcare of KS/MO 1996 - 1998
CIGNA Healthcare of CO 1993 - 1996
Telectronics 1991 - 1992
Education
University of Missouri-Kansas City 2007 — 2009
MBA, Operations Management
The University of Kansas 2002 — 2005
MHSA, Health Services Administration
Colorado State University 1984 — 1988
BSBA, Computer Information Systems
Neowell Systems January 2014 - Present
Wavefront Instruments January 2005 - June 2013
Cielo Communications 1998 - 2000
Telectronics 1995 - 1998
Telectronics Pacing Systems 1995 - 1998
Skills
Testing, Electrical Engineering, Engineering, Semiconductors, Embedded Software, Systems Engineering, System Design, Electronics, Debugging, Instrumentation, PCB design, Product Development, Microcontrollers, Product Management, C, Sensors, Firmware, R&D, Hardware Architecture, Embedded Systems, Engineering Management, Manufacturing, FPGA, System Architecture, Digital Signal..., Systems Design, PCB Design
Education
University of Colorado Boulder 1990 — 1992
Master’s Degree, Graduate work with emphasis on DSP
University of Colorado Denver 1986 — 1990
Baxter International Inc. December 2014 - Present
CONMED ELECTROSURGERY - CENTENNIAL, CO 2006 - Present
CONMED Corporation June 2006 - December 2014
CIVCO Medical Solutions 2002 - 2006
COBE Cardiovascular 2001 - 2002
Medtronic 1997 - 2001
Accufix Research Institute 1997 - 1999
Telectronics September 1995 - June 1997
Puritan Bennett 1993 - 1995
Skills
ISO 13485, Design Control, Medical Devices, Product Quality, FDA, Regulatory Affairs, Validation, 21 CFR Part 11, Regulatory Submissions, Quality System, V&V, Product Development, Root Cause Analysis, Medical Device Directive, Manufacturing, ISO 14971, Supplier Quality, Quality Auditing, CAPA, Quality Assurance, ISO, Six Sigma, Continuous Improvement, Biomedical Engineering, DMAIC, Design of Experiments, Iso 9000, Quality Control, GMP
Education
University of Iowa - Henry B. Tippie College of Business 2004 — 2006
MBA
University of Kansas Medical Center 1987 — 1991
University of Kansas 1983 — 1987
Bachelor of Arts (B.A.), Biology, General
CR BARD Lutonix May 2015 - Present
Bethel University August 2012 - Present
Sunshine Heart October 2014 - February 2015
Boston Scientific September 2012 - October 2014
Boston Scientific March 1997 - October 2014
Boston Scientific CRM 1997 - October 2014
Telectronics 1993 - 1997
Skills
Medical Devices, Clinical Research, Training, Product Development, FDA, Research, Biomedical Engineering, Design Control, Electrophysiology, Heart Failure, ISO 13485, R&D, Validation, Clinical Trials, V&V, Biotechnology, Cardiology, Commercialization, CAPA, Lifesciences, Troubleshooting, Biomaterials, Clinical Development, Cardiac Rhythm..., Pacemakers, GCP, Protocol, Hardware Diagnostics, Kinesiology, CTMS, Regulatory Affairs, PMA, Regulatory Submissions, GLP
Education
University of Denver 1986 — 1995
Ph.D. Research Design/Statistics Department of Education and M.A., Exercise Physiology/Research
CMDC Systems May 1995 - Present
Echostar November 1997 - November 2008
Medics/Ivion March 1990 - May 1995
Telectronics January 1985 - March 1990
Education
University of Southern California 1972 — 1986
MSSM, Systems and Information Managment
Bowling Green State University 1967 — 1972
BS, Livraty Science Physics Eductation
Shreve Research Inc September 2000 - Present
3Beez LLC 2009 - 2011
Wave Mechanics Engineering 1992 - September 2000
Telectronics 1992 - 1993
Datex-Ohmeda 1988 - 1992
Colorado Video 1987 - 1988
University of Colorado at Boulder 1985 - 1987
Skills
Medical Devices, Product Development, Quality System, FDA, Electrical Engineering, Start-ups, Design Control, Design for Manufacturing, CAPA, Testing, R&D, V&V, Hardware Architecture, Embedded Systems, ISO 13485, Commercialization, Biomedical Engineering, Space Systems, Engineering Management, Analog, EMC design, Agile Methodologies, Test Driven Development, Unit Testing, Arm Cortex-M4, ARM Cortex-M3, Arm Cortex-M0, Command and Data..., Spacecraft Design
Education
University of Colorado Boulder 1978 — 1982
BSEE, Electrical and Electronic Engineering
Morningstar Consulting Group LLC June 1997 - Present
ValveXchange, Inc. November 2010 - January 2015
Teleflex Medical April 2008 - April 2009
Edwards Lifesciences November 2006 - August 2007
Silverglide Surgical Technologies September 1998 - June 2006
Dolphin Medical January 1998 - December 2001
Tomtec Imaging Systems Inc. June 1995 - June 1997
Datex-Ohmeda 1988 - 1995
Telectronics 1985 - 1988
Cobe Laboratories 1983 - 1985
Skills
Medical Devices, Quality System, Design Control, Validation, Regulatory Affairs, GMP, ISO 13485, Regulatory Submissions, Start-ups, CE marking, Product Development, Manufacturing, Project Management, Clinical Trials, Strategy, Cross-functional Team..., Product Launch, Commercialization, V&V, Sterilization, Risk Management, Cardiovascular Devices, Angel Investing, Venture Capital, Due Diligence, Entrepreneurship, Six Sigma
Education
Michigan State University 1975 — 1980
Bachelor of Science (BS), Electrical and Electronics Engineering
St. Jude Medical June 2014 - Present
St. Jude Medical June 2004 - Present
St. Jude Medical May 2001 - May 2004
Telectronics November 1987 - November 1999
Michael Reese Hospital February 1985 - November 1987
Skills
Medical Devices, Pacemakers, Biomedical Engineering, Cardiac Rhythm..., Cardiology, Electrophysiology
Education
University of Illinois at Urbana-Champaign 1980 — 1984
St. Jude Medical April 1996 - Present
Telectronics May 1986 - March 1996
Cordis February 1980 - May 1986
Skills
Cardiology, Capital Equipment, Medical Devices, Pacemakers, Cardiac Surgery, Interventional..., Electrophysiology, Orthopedic, Market Development, Operating Room, Surgery, Disposables, Surgeons, Cath Lab, General Surgery, Surgical Instruments, Sales Management, Interventional Radiology, Neurosurgery, Vascular
Education
St. Francis College 1982 — 1984
Bachelor of Science (BS), Health Care Management
SUNY Albany 1971 — 1974
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse
Effective Compliance Solutions L.L.C. January 2012 - Present
Integra LifeSciences November 2010 - February 2012
Integra LifeSciences October 2007 - November 2010
Telectronics 1993 - 1997
Skills
Complaint Handling, Management Review, CAPA, Design Control, ISO 13485, Quality Systems, Process Validation, FDA, 21 CFR Part 11, Change Control, Validation, GMP, GLP, Quality Assurance, cGMP, Regulatory Affairs, Contract Manufacturing, Computer System..., SOP, Quality Auditing, Supplier Quality, Medical Devices, Document Management, Quality Management, Auditing, Continuous Improvement, Process Improvement, Biotechnology, CMDCAS, MDD, Risk Management, Regulatory issue..., ISO, ISO 14971, Quality System, Pharmaceutical Industry, DMAIC, Biopharmaceuticals, Quality Control, V&V, Regulatory Submissions, SPC, R&D, Technology Transfer, GxP, Sop, Iso 9000, Biomedical Engineering, Medical Device Directive, Six Sigma
Education
University of Phoenix 1991 — 1991
Motorola September 1999 - Present
Motorola 1999 - 2008
Motorola 1999 - 2008
Motorola 1993 - 2008
ACR Electronics Inc. 1996 - September 1999
Telectronics 1993 - 1996
Pilkington 1987 - 1993
Libbey-Owens_ford 1987 - 1993
Libbey-Owens-Ford 1986 - 1993
LOF Glass 1986 - 1993
Education
University of Florida
Masters of Engineering, Mechanical Engineering, Polymneric Materials
University of Toledo 1989 — 1993
BSME, Mechanical Design
Owens Community College 1984 — 1986
Drafting
Histogenics Corporation August 2013 - Present
Covidien June 2011 - July 2013
Covidien June 2010 - June 2011
Covidien, Surgical Devices June 2009 - June 2010
Covidien August 2006 - June 2009
Confluent Surgical June 2001 - August 2006
Boston Scientific June 1999 - May 2001
Computer Motion Incorporated April 1998 - April 1999
Biotronik April 1997 - April 1998
Telectronics June 1996 - December 1996
Skills
FDA, Clinical Affairs, Medical Devices, Design Control, ISO 13485, Regulatory Affairs, Clinical Trials, CAPA, Clinical Development, Biomedical Engineering, PMA, Biotechnology, Regulatory Submissions, CTMS, Commercialization, Validation, Lifesciences, GCP, Operating Room, Clinical Research, Cardiology, CRO, Oncology, Pharmaceutical Industry, Global Drug Development, Drug Development, Life Sciences
Education
Cleveland State University
Bachelor's Degree, Biology
Retired September 2013 - Present
International Institute of Business Analysis 2008 - 2015
International Institute of Business Analysis 2008 - 2015
The George Washington University July 2001 - September 2013
S.C.T 2000 - 2001
John Alden Life Insurance Company 1990 - 1999
Telectronics 1985 - 1988
Cordis Corporation 1980 - 1984
University of Miami 1979 - 1980
miami dade schools 1974 - 1979
Skills
Business Analysis, Business Intelligence, Business Process..., Leadership, Program Management, Analysis, Data Analysis, Systems Analysis, Project Management, Requirements Analysis, Management, IT Strategy, Software Project..., SDLC, Risk Management, Visio, Business Process, Requirements Gathering, Enterprise Architecture, Integration, Project Planning, Software Development, Oracle, Change Management, IT Service Management, ITIL, Vendor Management, Governance, Process Improvement, Databases, Process Engineering, Strategy, Data Modeling, Budgets, ERP, Business Development, Team Management, Customer Service, Strategic Planning, Team Building, Security
Education
Tulane University
BS, Mathematics
University of Miami
Master of Arts (MA), Mathematics
Cisco Systems July 2012 - Present
NETGEAR April 2012 - June 2012
Cisco Systems February 2006 - October 2011
Scientific Atlanta 2002 - 2005
PowerTV 2000 - 2001
Acuson 1994 - 2000
Telectronics 1988 - 1994
Skills
Android Development, C/C++, Java, JNI, Linux, Windows, Ant, RTOS, Embedded Software, Embedded Systems, OCAP, Agile SW Developement, Embedded HTML Engine, HTML, HTML5, Cables, Android
Education
Case Western Reserve University 1984 — 1987
MS
Zhejiang University 1977 — 1981
B.S.
Boston Scientific July 2004 - March 2012
Althin Medical, Inc. 1997 - 2002
Telectronics 1992 - 1997
Telectronics 1987 - 1992
Skills
Quality System, Design of Experiments, ISO 14971, Testing, Validation, Automation, Design Control, Minitab, Gage R&R, FDA, GMP, FMEA, Biomedical Engineering, Six Sigma, V&V, ISO 13485, Medical Devices, Root Cause Analysis, CAPA, CQE, ISO, SPC, DMAIC, Inspection, Process Capability, Quality Assurance, Continuous Improvement, Lean Manufacturing, Manual Testing, Quality Management, 21 CFR Part 11, Quality Control, Process Simulation, Manufacturing
Education
Florida International University 1978 — 1980
BS, Electrical Engineering
Western Emulsions January 2013 - Present
FCC Environmental March 2008 - December 2012
Siemens Water Technologies 2001 - 2008
Finzer Imaging March 1999 - June 2001
Language Management International August 1997 - January 1999
Telectronics April 1994 - August 1997
Telectronics April 1985 - March 1994
Telectronics February 1983 - March 1985
Telectronics February 1980 - January 1983
Koss Corporation June 1973 - February 1980
Skills
CPA, CMA, CGMA
Education
Marquette University 1973 — 1979
BS in Business Administration, Accounting
Broward College July 2010 - Present
Miami Dade College January 2010 - June 2010
AT&T August 2006 - June 2010
Miami Dade College September 2000 - August 2006
BellSouth June 1998 - August 2006
Miami Dade College September 1993 - June 1998
Florida International University January 1993 - August 1993
Telectronics August 1987 - January 1993
Cordis September 1986 - August 1987
Homestead Air Force Base September 1979 - August 1986
Skills
Student Affairs, Campus, Student Financial Aid, Admissions, Time Management, Career Counseling, Enrollment Management, Academic Administration, Resume Writing, Distance Learning, Instructional Design, Academic Advising, Student Development, Teaching, Leadership Development
Education
Florida International University 1993 — 1994
Master of Public Administration (17 semester hours completed)
Florida International University
Bachelor of Arts, Liberal Studies
Miami Dade College
Associate in Science, Electronics Engineering Technology
South Dade High School
Diploma
The West Clinic July 2013 - Present
Adrian Blotner, MD April 2013 - July 2013
St. Jude Medical April 2004 - November 2012
Medtronic February 2001 - April 2004
St. Jude Medical July 1997 - February 2001
Telectronics January 1992 - July 1997
Skills
Cardiology, Heart Failure, Clinical Trials, Nursing, Pacemakers, Cardiac, Electrophysiology, Medical Devices, Clinical, Interventional..., Clinical Research, Critical Care, Cath Lab, Nurse Practitioners, Cardiac Rhythm..., Hospitals, Healthcare, Cardiac..., Telemetry, Defibrillator, Acute Care, Catheters, Hardware Diagnostics, Spine, Operating Room, Medicine, EMR, Biomedical Engineering, EHR, GCP, ACLS, Internal Medicine, Protocol, Stents, Icd, Product Launch, Oncology, ICU, BLS, Biotechnology, Radiology, Cardiac Care, Healthcare Industry, Market Development, Vascular, Orthopedic
Education
University of Southern Indiana 2009 — 2012
MSN-FNP, Nursing
University of Phoenix 2005 — 2008
BSN, Nursing
Methodist Hospital School of Nursing 1979 — 1981
Diploma in Nursing, Nursing
The University of Memphis 1978 — 1980
Nursing
Immaculate Conception High School 1970 — 1974
GE Healthcare November 2014 - Present
GE Healthcare September 2013 - November 2014
Sound Technology, Inc. November 2010 - September 2013
W.L. Gore & Associates January 2009 - November 2010
W.L. Gore & Associates April 2005 - January 2009
Tetrad Corp. July 1997 - April 2005
Telectronics March 1996 - July 1997
Saturn June 1990 - March 1996
Skills
Product Development, Lean Manufacturing, Medical Devices, Program Management, Continuous Improvement, Engineering, ISO, Manufacturing, Process Engineering, Change Management, Process Improvement, Supply Chain Management, Product Design, Problem Solving, 5S, R&D, Kaizen, Team Leadership, Cross-functional Team..., Supply Chain, Product Launch, Product Management, Cost Reduction, New Business Development, Team Management, SPC, FDA, Operational Excellence, Operations Management, Design of Experiments, Quality System, Design Control, Engineering Management, FMEA, Manufacturing...
Education
Oakland University 1991 — 1993
MBA
Calvin College 1986 — 1990
BSE, Mechanical Engineering
M H Carnegie & Company / Australian Medtech Services October 2013 - Present
TM Strategic Advisors LLC 2010 - Present
Center for Infectious Disease Research August 2005 - Present
Frazier Healthcare Ventures 1999 - 2010
The Wilkerson Group 1996 - 1999
Ventritex 1995 - 1996
Telectronics 1987 - 1993
Skills
Lifesciences, Medical Devices, Global Business..., Start-ups, Venture Capital, Partnerships, Managerial Finance, Commercialization, Financial Reporting, Corporate Development, Private Equity, Financial Services, Public Speaking, Executive Management, Licensing, Strategy, Technology Transfer, Due Diligence, Biotechnology, Entrepreneurship, Business Planning, Business Development, Mergers & Acquisitions, Cardiology, Investments, FDA, Healthcare
Education
Massachusetts Institute of Technology - Sloan School of Management 1993 — 1995
SM, Business
University of Southern Queensland 1983 — 1986
Bachelor Engineering, Electrical / Biomedical
Angel Medical Systems November 2009 - Present
BIOTRONIK March 2001 - December 2008
Boston Scientific January 1999 - June 2002
Telectronics November 1989 - May 1998
CPI 1988 - 1990
Medtronic July 1984 - November 1989
Education
Northern Virginia Community College 1976 — 1978
Dream Weaver Dive Center May 2011 - Present
Trip N Tour Pacific October 1999 - May 2011
Telectronics October 1994 - June 1999
Skills
Adventure Travel, Tourism, Leisure, Resorts, Hospitality, Vacation, Hotels, Ski, Event Management, Sports, Travel Planning, Photography, Scuba Diving, Incentives, Honeymoons, Event Planning, Customer Service, Cruises, Leisure Travel, Car Rental, Social Media Marketing
Education
University of Colorado Boulder 1981 — 1985
BS, Exercise Physiology
University of Colorado at Boulder
Bachelor of Science (B.S.)
Thompson School District January 2006 - Present
Telectronics 1990 - 1992
Spectra-Physics 1984 - 1989
Skills
Crafting, Classroom para
Education
Centenary College 1977 — 1979
Interior design
St. Marks 1974 — 1977
BIOTRONIK Field EngineerBIOTRONIKJanuary 1999 - April 2012
InControl 1996 - 1999
Telectronics 1993 - 1996
Montefiore Medical Center 1987 - 1993
Military January 1984 - January 1984
Skills
Electrophysiology, Medical Devices, Biomedical Engineering, Medical Imaging, Catheters, Cardiology, ISO 13485, FDA, Military Skills, Capital Equipment, Clinical Trials, Clinical Research
Education
City University of New York
Bachelors of Engineering, Electro-Mechanical Engineering
Bronx Community College
Associates in Applied Science, Engineering
International Board of Heart Rhythm Examaners
Certified Cardiac Device Specialist (CCDS), Cardiac Rhythm Management (CRM) devices
NCO Academy
Senior Advance Course, Senior NCO Leadership, Honor Graduate
Instructor Training Academy
Senior Instructor, Distinguished Graduate
Leadership Training Institute
Leadership Training and Counseling
Sales and Management Training Institute
Leadership, Human relations, Motivation and Management Development-Special Recognition Award
American Health Care Academy
CPR/AED Course
ITW Industrial Finishing 1997 - 2007
Telectronics 1995 - 1997
Golden Photon 1994 - 1995
Tierra Constructors inc. 1992 - 1994
Hamilton Sundstrand 1979 - 1991
Skills
Lean Manufacturing, Manufacturing, Mechanical Engineering, Engineering, Solidworks, Sheet Metal, AutoCAD, Metal Fabrication, Automotive, Design for Manufacturing, Pro Engineer
Education
Front Range Community College
Associate of Science (A.S.), Hazardous Materials Management and Waste Technology/Technician
University of Phoenix
Bachelor's degree, Business, Management, Marketing, and Related Support Services