Terumo Cardiovascular Systems
Industry: Company
DescriptionFounded: 1999 Parent organization: Terumo Medical Corporation
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Terumo Cardiovascular Systems Employees
Urban Science November 2014 - Present
Chrysler Academy March 2013 - May 2013
Cytec September 2012 - October 2012
Terumo Cardiovascular Systems August 2011 - August 2012
Raytheon Professional Services 2009 - 2011
Walsh College 2007 - 2009
General Physics Corporation 1997 - 2006
Skills
Personal Branding, Instructional Design, Tutoring, Analysis, Blended Learning, Instructor-led Training, ADDIE, Needs Analysis, E-Learning, Learning Management, Performance Consulting, Technical Training, Learning Management..., Camtasia, Training, Lectora, Curriculum Design, Organizational..., ILT, Employee Training, Instructional Technology, Leadership, Human Performance, Distance Learning, Technical Writing, Curriculum Development, Adult Education, Training Delivery, Workshop Facilitation, Organizational Learning, Staff Development, SCORM, Adult Learning Theory, Hands-on Training, Training Needs Analysis, WebEx, Performance Improvement
Education
University of Michigan-Dearborn 2003 — 2005
MA, Performance Improvement and Instructional Design
Oakland Community College
AA, Liberal Arts
Oakland University
BS, Human Resources Development
Ross Medical Education
Medical Office Assistant/Specialist
Terumo Cardiovascular Systems February 2012 - Present
Hospira November 2011 - February 2012
CIBA Vision April 2011 - October 2011
Stryker June 2010 - March 2011
Zimmer October 2000 - September 2009
Skills
Certified Lead Auditor, ASQ CQA, FDA, ISO 13485, Consent Decree, Rescue Compliance, Quality Assurance, Quality Management, SAP R/3, Trackwise, 21 CFR Part 11, 21 CFR 820, CAPA, Validation, ASQ, 21 CFR, Quality System, Medical Devices, GMP, Root Cause Analysis, Auditing, Computer System..., Supplier Quality, FDA GMP, FMEA, V&V, Minitab, ISO, Quality Control, Change Control, DMAIC, Quality Auditing, ISO 14971, SPC
Education
Purdue University 1994 — 1998
Bachelor's degree, Industrial Engineering
General Motors April 2015 - Present
Henglong USA Corporation September 2014 - January 2015
Terumo Cardiovascular Systems June 2014 - August 2014
University of Michigan Mechanical Engineering January 2014 - April 2014
Fraunhofer USA May 2013 - August 2013
GEA Group June 2011 - September 2011
Shanghai Electric Group Co., Ltd July 2009 - October 2009
Skills
Matlab, Solidworks, AutoCAD, Labview, Minitab, C++, UGS NX5, ADAMS, Simulink, PAMs, Manufacturing..., Manufacturing Techniques, SolidWorks, Mechanical Engineering, ANSYS, Finite Element Analysis, MATLAB, Pro Engineer, LabVIEW
Education
University of Michigan 2013 — 2015
Master's degree, Mechanical Engineering
University of Michigan 2012 — 2014
Master's degree, Manufacturing Engineering
Shanghai Jiao Tong University 2008 — 2012
Bachelor's degree, Mechanical Engineering
Nanyang Technological University 2010 — 2011
Mechanical Engineering
Wurtec June 2015 - Present
Terumo Cardiovascular Systems June 2013 - June 2015
Invacare October 2012 - June 2013
Terumo Heart Inc. March 2012 - October 2012
Fresenius Medical Care January 2011 - March 2012
Fresenius Medical Care North America July 2004 - January 2011
Fresenius Medical Care North America December 2000 - July 2004
Skills
Fine Art Photography, Photo Editing, Creative Writing, Medical Devices, Document Management, Technical Documentation, Quality Assurance, Quality Systems, Social Media Marketing, Web 2.0, Quality Auditing, Internal Audit, Supplier Auditing, ISO standards, ISO 13485, Risk Management, Risk Analysis, Root Cause Analysis, Team Building, Supplier Quality, Process Improvement, CAPA, Cross-functional Team..., cGMP, Digital Photography, Portrait Photography, Business Portraits, Event Photography, Writing, Web Design, FMEA, Quality System, 21 CFR, Part 820, DFMEA, Quality System..., Microsoft Excel, Microsoft Office, Microsoft Word, GMP, Business Process Mapping, Continuous Improvement..., Change Control, V&V, Design Control, ISO, Image Editing, Auditing, Lean Manufacturing, Quality Control
Education
University of Toledo 2007 — 2009
Bachelor of Business Administration, Electronic Commerce
Owens Community College 2000 — 2006
Associate of Science, Business Administration Concentration
Bowsher 1994 — 1999
High School Diploma, Marketing
ACIST Medical Systems April 2013 - Present
Boston Scientific July 2003 - April 2013
Perrigo November 2001 - July 2003
Terumo Cardiovascular Systems April 2000 - October 2001
W.L. Gore March 1996 - April 2000
Skills
CAPA, Medical Devices, 510 K, Quality Engineering, PMA, Combination Products, Quality Management, Quality Auditing, Design of Experiments, Project Planning, Project Management, OTC, Pharmaceutical Industry, ANDA, FDA, ISO 13485, ISO 17025, Root Cause Analysis, Due Diligence, Integration, New Business Development, Strategic Planning, Supplier Quality, OEM Management, Contract Manufacturing, Quality Assurance, Quality Control, Validation, Quality System, Design Control, Analytical Chemistry, ISO 14971, 21 CFR, V&V, GMP, Product Development, Change Control, CE marking, Process Improvement, Cross-functional Team...
Education
US Navy 1987 — 1994
Electronics Technology/Navy Aircrew
Richard Stockton College of New Jersey
Bachelor of Science (B.S.), Analytical Chemistry
Medline Industries, Inc. September 2014 - Present
Baxter March 2014 - September 2014
Terumo Cardiovascular Systems September 2011 - March 2014
University of Toledo January 2009 - August 2009
Boston Scientific August 2008 - July 2009
University of Toledo May 2008 - August 2008
The University of Toledo August 2007 - December 2007
Owens Community College June 2006 - August 2006
Owens Community College August 2005 - May 2006
Skills
Medical Devices, FDA, Biomedical Engineering, V&V, Validation, GMP, Microsoft Office, Design of Experiments, Mechanical Testing, ISO 13485, Quality System, Matlab, Design Control, Regulatory Affairs, CAPA, ISO 14971, SolidWorks, 3D rendering, Dimensioning, ISO 10993, Biocompatibility, Calibration, GLP, FDA GMP, 21 CFR, Bilingual, Non product software..., Performance of medical..., Medical Translation, Technical Translation, pharmaceutical water..., Cleaning Validation
Education
University of Toledo 2008 — 2011
Engineering, Biomedical Engineering
Owens Community College 2004 — 2007
Associate of Science, Concentration Mathematics
Edwards Lifesciences May 2013 - Present
Mission Hospital July 2007 - May 2013
Terumo Cardiovascular Systems 2002 - 2006
Skills
Market Development, Healthcare, Biotechnology, Medical Devices, Product Launch
Education
Pepperdine University, The George L. Graziadio School of Business and Management
Terumo Cardiovascular Systems January 2013 - Present
CUA Department of Biomedical Engineering September 2009 - May 2012
Cross Medical Specialties Inc. May 2009 - September 2009
Skills
Matlab, Microsoft Office, AutoCAD, SketchUp, Customer Service, Research, Public Speaking, Solidworks, Teaching, Microsoft Word, Microsoft Excel, Biomedical Engineering, PowerPoint, Statistics, Data Analysis, Leadership, Teamwork, Medical Devices
Education
The Catholic University of America 2008 — 2012
Bachelor's of Biomedical Engineering, Biomedical/Medical Engineering
Terumo Cardiovascular Systems October 2013 - Present
Catalent Pharma Solutions May 2012 - October 2013
BD September 2009 - May 2012
BD April 2008 - August 2009
BD July 2006 - March 2008
BD April 2005 - June 2006
Covidien October 2004 - April 2005
Covidien February 2004 - October 2004
Covidien July 2002 - February 2004
Covidien January 2002 - July 2002
Skills
Lean Manufacturing, Continuous Improvement, Value Stream Mapping, Six Sigma, 5S, Kaizen, Supply Chain, Production Planning, Materials Management, Quality Systems, MRP, Cost Reduction, ISO, Kanban, Manufacturing Operations, Operational Excellence, Cross-functional Team..., Process Improvement, Manufacturing Management, Manufacturing, SAP, Operations Management, Medical Devices, FDA, Injection Molding, GMP, Root Cause Analysis, FMEA, Logistics, CAPA, Quality System, Validation, Quality Control, ISO 13485, V&V, Pharmaceutical Industry, Contract Manufacturing, Quality Management, Design of Experiments, SPC, Change Control, Sop, DMAIC, Process Simulation, Manufacturing..., Manufacturing..., SOP
Education
Webster University 2005 — 2008
MBA
The Citadel 1994 — 1998
BS, Physics
Bosch North America February 2015 - Present
ZF Lenksysteme GmbH June 2012 - February 2015
Terumo Cardiovascular Systems December 2010 - June 2012
Delphi October 1993 - November 2010
Nexteer Automotive May 1993 - November 2010
Delphi Steering 1999 - 2009
USMC 1983 - 1987
Skills
Requirements Analysis, Project Management, Six Sigma, Engineering Management, FMEA, Integration, Product Development, Lean Manufacturing, Systems Engineering, Testing, Cross-functional Team..., Process Improvement, Program Management, Strategic Planning, Kaizen, Quality Assurance, Automotive, Continuous Improvement, Embedded Systems, Change Management, Risk Management, Software Engineering, Visual Basic, Software Design, Product Management, Business Process..., Coaching, Leadership, Operational Excellence, Quality Management, DFSS Black Belt, Red X, Rolling Top 5
Education
Rensselaer Polytechnic Institute - The Lally School of Management and Technology 1996 — 2001
Masters, Engineering
UOP October 2014 - Present
UOP October 2011 - October 2014
ExxonMobil July 2010 - October 2011
ExxonMobil August 2009 - July 2010
ExxonMobil June 2008 - August 2009
ExxonMobil July 2007 - July 2008
Terumo Cardiovascular Systems 2005 - 2007
General Electric May 2006 - August 2006
Skills
Chemical Engineering, Refining, Process Engineering, Refinery, Oil/Gas, Technical Sales..., Technical Writing, Energy, Engineering, Factory, R&D, Manufacturing, Design of Experiments, SAP
Education
The University of Chicago - Booth School of Business 2013 — 2016
University of Michigan 2003 — 2007
Bachelors of Science, Chemical Engineering
Zynga November 2014 - Present
Amazon (AWS) July 2013 - Present
Intel Corporation May 2012 - August 2012
Terumo Cardiovascular Systems 2012 - 2012
Intel Corp - Litigation, Licensing, and Patent Group November 2007 - 2011
Blakely Sokoloff Taylor & Zafman 2007 - 2009
Agilent Technologies 2004 - 2007
Skills
Cross-functional Team..., Patents, Business Strategy, Patent Prosecution, Research, Qualitative Research, Mergers & Acquisitions, Competitive Analysis, Patent Litigation, Circuit Design, Legal Research, European Law, Intellectual Property, Strategy, Multinational, Language Development, Patent Drafting, Language Skills, International Business, Genetic Programming, Artificial Intelligence, Contract Negotiation, SQL, Data Analysis, Cloud Computing, Product Management
Education
University of Michigan - Stephen M. Ross School of Business 2011 — 2013
Master of Business Administration (MBA), Business Administration and Management, General
National University of Singapore
Ph. D., Computer Engineering
Thermo Fisher Scientific July 2015 - Present
Thermo Fisher Scientific January 2014 - Present
Terumo Cardiovascular Systems October 2012 - January 2014
University of Michigan Ross School of Business, Kresge Library April 2011 - August 2012
University of Michigan Ross School of Business, Business Strategy Department July 2011 - October 2011
University of Michigan Ross School of Business, Kresge Library September 2010 - April 2011
The Paley Center for Media February 2011 - February 2011
Wittenberg University, Thomas Library August 2006 - August 2010
Skills
Program Management, Technical Writing, Management, ISO 13485, FDA, Medical Devices, Data Analysis, Quality Assurance, Document Management, Change Management, Validation, Research, Change Control, Risk Management, GDP, Consent Decree, Risk Analysis, V&V, Cross Functional Team..., Project Coordination, Process Improvement, SAP, 21 CFR Part 11, Project Management, Change Orders, SOP authoring, Change Order Analysis, Metadata, Remediation, SOP development, Technical Reviews, Hazard Analysis, Quality Control, CAPA, Cross-functional Team..., Analysis, Editing, Quality System, Critical Thinking, ITIL, GAMP, ISO 9001
Education
University of Michigan - School of Information 2010 — 2012
Master of Information, School of Information
Wittenberg University 2006 — 2010
BA, Business Management
Royal Holloway, U. of London 2008 — 2008
School of Management
Terumo Medical Corp, April 2015 - Present
Terumo Cardiovascular Systems April 2015 - Present
Hospira June 2012 - July 2014
Uresil LLC November 2005 - April 2012
Atek Medical (Formerly Medtronic) July 1996 - July 2005
Glacier Vandervell Inc. January 1994 - July 1996
Blairden Precision Instruments August 1992 - July 1993
Allied Signal Aerospace Company February 1977 - April 1992
Skills
Injection Molding, Pro Engineer, Solidworks, Design Control, Root Cause Analysis, Manufacturing, Validation, CAD, Medical Devices, CAPA, Product Design, Product Development, R&D, Engineering, Process Simulation, Quality System, Lean Manufacturing, Mechanical Engineering, Testing, Six Sigma, Continuous Improvement
Education
University of Missouri-Columbia 1975 — 1977
Master's degree, Mechanical Engineering
Rockhurst College 1971 — 1975
Bachelor's degree, Engineering Science
Berry Plastics December 2004 - Present
Innovative Plastic Solutions 2003 - 2004
Terumo Cardiovascular Systems June 1999 - June 2003
Skills
Injection Molding, Manufacturing, Plastics, Extrusion, Blow Molding, Packaging, ISO 13485, Manufacturing..., Quality System, Molding
Education
Pennsylvania College of Technology 1996 — 1999
Bachelor's degree, Platics & Polymer Engineering Technology
Fish & Richardson P.C. March 2012 - Present
Terumo May 2010 - August 2011
Terumo Cardiovascular Systems July 1999 - May 2009
Skills
Quality System, Intellectual Property, Medical Devices, Legal Research, Contract Negotiation, Negotiation, Pharmaceutical Industry, Biotechnology, Project Management, Contract Management, Product Development, Strategic Planning
Education
University of Michigan Law School 2009 — 2011
Juris Doctor, Law
North Dakota State University
Bachelor of Science (BS), Mechanical Engineering
Terumo Cardiovascular Systems September 2012 - Present
Terumo Cardiovascular Systems March 2012 - September 2012
Brunnschweiler, USA October 2010 - October 2011
LabtronX August 2006 - July 2010
University of Memphis August 2004 - June 2006
NASA Glenn Research Center June 2004 - August 2004
Skills
Biomedical Engineering, Electronics, Medical Devices, Product Development, CAPA, FMEA, Quality System, Quality Assurance, ISO 13485, IEC 60601, Testing, Research, R&D, Troubleshooting, Photovoltaics, Microcontrollers, Problem Solving, Team Leadership, Supervisory Skills, FDA, Root Cause Analysis, Engineering, Continuous Improvement, Community Outreach
Education
The University of Memphis 2004 — 2006
Bachelor of Science, Electronic Engineering Tech & Biomedical Eng.
Nashville State Community College 2002 — 2004
A.A.S., Electronic Eng. Tech.
Gentherm (formerly Amerigon) May 2006 - Present
Lear Corporation 2000 - 2006
Terumo Cardiovascular Systems 1996 - 2000
Straith Hospital for Special Surgery 1991 - 1996
Skills
Supplier Quality, Quality System, FMEA, Product Development, Six Sigma, Manufacturing, Quality Management, Kanban, DFMEA, Lean Manufacturing, APQP, TS16949, ISO, Root Cause Analysis, TQM, Value Stream Mapping, GD&T, SPC, DMAIC, Engineering, Supply Management, Quality Assurance, Automotive, Quality Auditing, Manufacturing..., Continuous Improvement, PPAP, 5S, Poka Yoke, Manufacturing..., Project Management, Kaizen, Process Improvement, Medical Devices, Manufacturing Operations, Product Quality, 5 Why, Process Capability, Toyota Production System, Quality Control, Supplier Quality..., Engineering Management, Green Belt, ISO/TS 16949, Cross-functional Team...
Education
Walsh College 2004 — 2006
MSM, Management
St. John Hospital - Clinical Internship 1990 — 1991
BS, Clinical Laboratory Science
Michigan Technological University 1986 — 1991
BS, Medical Technology
Shaqe's art class in Ypsi
Terumo Cardiovascular Systems 2012 - Present
Continental Automotive Systems 2011 - 2012
Continental Automotive Systems 2009 - 2011
Continental Automotive Systems Former Siemens VDO 2007 - 2009
Continental Automotive Systems Former Siemens VDO 2005 - 2007
Continental Automotive Systems Former Siemens VDO 2004 - 2005
Lear Corporation 2000 - 2004
Skills
Change Management, Customer Service, Automotive, FMEA, PPAP, APQP, Continuous Improvement, Six Sigma, Root Cause Analysis, Lean Manufacturing, Medical Devices, SPC, DMAIC, Engineering Management, Design for Manufacturing, Cross-functional Team..., Product Development, DFMEA, Quality Management, Quality System, Supplier Quality, Manufacturing, Powertrain, Automotive Engineering, Mechanical Engineering, Product Launch, Vehicles, FDA, Design Control, Electrical Engineering, V, Product Management, ISO 13485, Electronics, Product Design, Value Stream Mapping, Manufacturing..., Injection Molding, Kaizen
Education
Oakland University 1997 — 2000
Bachelor of Science (B.S.), Mechanical Engineering
Terumo Cardiovascular Systems January 2003 - August 2003
Kwikset Corp. November 1991 - May 1998
GM Hughes Electronics Corp. August 1987 - July 1991
Hughes Aircraft Company - Ground Systems Group February 1983 - August 1987
Fluor Engineers and Constructors July 1980 - July 1982
Skills
PLC, Industrial Controls, Automation, Lean Manufacturing, Process Development, Continuous Improvement, Troubleshooting, Project Engineering, Capital Acquisition, Control System Design, Equipment Acquisition, Industrial Control
Education
Stark State College of Technology 2009 — 2010
Certificate, Fuel Cell Technology
The University of Akron 1975 — 1980
BS, Mechanical Engineering
Bevi April 2014 - Present
Terumo Cardiovascular Systems October 2013 - April 2014
Philips Color Kinetics July 2012 - December 2012
Hologic July 2011 - December 2011
New Objective Inc. July 2010 - January 2011
Skills
Solidworks, Machining, Mechanical Engineering, Design Engineering, Product Development, Design for Manufacturing, Engineering, Materials, Design of Experiments, SolidWorks, Manufacturing
Education
Northeastern University 2008 — 2013
Bachelor of Science (B.S.), Mechanical Engineering, Minor Concentration: Electrical Engineering
Terumo Cardiovascular Systems 2014 - Present
Cummins Northeast, LLC May 2013 - November 2013
The Brickle Group October 2012 - May 2013
The Brickle Group September 2010 - October 2012
MicroGroup March 2010 - August 2010
Vacumet Corp June 2009 - March 2010
Symmetry Medical July 2008 - August 2009
Reiser June 2006 - July 2008
GTE Government Systems 1988 - 1992
Skills
Strategic Human..., Organizational..., Talent Management, Workforce Planning, Change Management, Performance Management, Coaching, Process Improvement, College Recruiting, Employee Relations, Lean Manufacturing, Organizational..., Policy and Program..., Project Management, Safety, Training, Training Grants, Experiential Learning, Total Rewards Strategies, Employer Branding, Onboarding, Advanced Manufacturing, Community Relations, Human Capital, HRIS, STEM, Technical Recruiting, HR Consulting, Personnel Management, Conflict Resolution, Recruiting, Leadership, Management, Succession Planning, Employee Engagement, Benefits Administration, HR Policies, Sourcing, Applicant Tracking..., Manufacturing
Education
Northeastern University 1983 — 1988
Bachelor of Science, Speech Communication, Minor Business Administration, cum laude
Terumo Cardiovascular Systems December 2013 - Present
TERUMO CARDIOVASCULAR SYSTEMS December 2013 - Present
BD 2013 - 2013
Testing Machines Inc. December 2011 - September 2012
Cobham Defense Electronic Systems January 2005 - August 2010
Davis Calibration March 2002 - December 2004
Ciena December 2000 - March 2002
Raytheon March 1994 - February 2000
Skills
Quality Assurance, Electronics, ISO, Six Sigma, Test Equipment, Calibration, Inspection, Internal Audit, Manufacturing, Measurement Uncertainty, Process Control, Procedure Development, Systems Engineering, CAPA, RF, Spectrum Analyzer, 5S, Quality Control, SPC, Quality System, Quality Management
Education
American Association for Laboratory Accreditation (A2LA)
Industry Certification, Measurement Uncertainty Science
Cayuga County Community College
Associate in Applied Science, Electronics / Electrical Technology, 3.4
National Institute of Standards & Technology
Mass Metrology
The Johns Hopkins University
Technical and Business Writing
US Air Force Technical Training School, Lowry AFB
Advanced & Microwave Measurement and Calibration
US Naval Training Center Great Lakes
Basic Electronics
US Naval Training Center Great Lakes
Electronics Technician "A" School (Radio and Radar), 3.8 (1st in Class)
Terumo Cardiovascular Systems April 2014 - Present
Salisbury University Microbiology Department August 2009 - June 2010
Skills
CAD, Product Development, Matlab, Microsoft Office, Microbiology, Product Management, Finite Element Analysis, Marketing
Education
University of Maryland College Park 2010 — 2013
Bachelor of Science (BS), Mechanical Engineering
Salisbury University 2008 — 2010
Biology, General
Invacare Corporation September 2015 - Present
Invacare Corporation September 2013 - Present
YMCA May 2005 - September 2013
Terumo Cardiovascular Systems January 2011 - December 2011
Skills
Solidworks, MathCAD, Pspice, Matlab, Minitab, Microsoft Office
Education
Ohio University 2014 — 2017
Master's degree, Engineering Management
University of Toledo 2008 — 2013
Bachelor's degree, Bioengineering and Biomedical Engineering
Terumo Cardiovascular Systems July 2012 - Present
Terumo Cardiovascular Systems July 2008 - July 2012
Terumo Cardiovascular Systems August 2002 - July 2008
Terumo Cardiovascular Systems September 2001 - July 2002
Skills
ASQ member, IPC, J-STD-001, Acceptance Sampling, Micrometer, Measurement Tools, Calipers, Instron, Optical Comparator, ASQ Member, Quality Assurance, Quality System, Validation, ISO 13485, Design Control, CAPA, Testing, ISO 14971, Medical Devices, FDA, ISO, Root Cause Analysis, FMEA, SPC, Manufacturing
Education
University of Phoenix 2002 — 2002
Monroe County Community College 1999 — 2000
Tecumseh High School 1994 — 1998
Placek & Associates, LLC08/14- present August 2014 - Present
Abbott Vascular July 2013 - November 2013
Terumo Cardiovascular Systems January 2012 - March 2013
St. Jude Medical NeuroModulation Division October 2011 - January 2012
Volcano Corporation February 2011 - September 2011
Spinal Modulation March 2010 - February 2011
Genentech October 2008 - July 2009
Theranos October 2006 - January 2008
Skills
FDA, Medical Devices, Test Automation, Windows, GUI, Agile Methodologies, Testing, Design Control, Validation, ISO 13485, Test Planning, SDLC, CAPA, Visual Studio, C, Integration, Quality System, Embedded Systems, 21 CFR Part 11, R&D, Automation, Debugging, V&V, Databases, Software Development, Quality Assurance, Device Drivers, Embedded Software, Labview
Education
Sun Microsystems 2000 — 2000
Java2 “Bootcamp” Programmer Certification, Java 2 Certification
UC San Diego 1989 — 1989
C Programming and Systems Design
National University 1981 — 1984
Computer Science, B.S., Computer Science
National University
Delphinus Medical Technologies, Inc. August 2014 - Present
Terumo Cardiovascular Systems June 2014 - August 2014
Terumo Cardiovascular Systems January 2012 - June 2014
Terumo Cardiovascular Systems December 2010 - May 2012
Link Engineering Company June 2010 - November 2010
TRW February 2010 - May 2010
TRW September 2003 - June 2009
2003Emergent Systems August 2002 - September 2003
TRW May 2002 - August 2002
Skills
Matlab, Programming, Process Engineering, Data Analysis, Operating Systems, Microsoft Excel, Microsoft Word, Quality Assurance, Risk Management, Medical Devices
Education
Michigan Technological University 1998 — 2002
BSME, Mechanical Engineering
NSK November 2013 - Present
Terumo Cardiovascular Systems June 2013 - October 2013
Terumo Cardiovascular Systems June 2011 - June 2013
Terumo Cardiovascular Systems November 2009 - June 2011
Whirlpool Corporation August 2008 - November 2009
Whirlpool Corporation March 2008 - August 2008
Whirlpool Corporation May 2007 - February 2008
Caterpillar Inc. August 2005 - December 2005
Coach's Catastrophe Cleaning & Restoration Services June 1999 - August 2005
Skills
Failure Analysis, Corrosion, Fluid Mechanics, Heat Transfer, Thermodynamics, Material Selection, Biomechanics, Metallurgy, FMEA, Mechanical Testing, Continuous Improvement, Reliability, Stainless Steel, Aluminum, Iron, Biomaterials, Materials Science, Product Engineering, Process Capability, Materials, Design of Experiments, DOE, Steel, Manufacturing, Root Cause Analysis, Quality System, Minitab, Medical Devices, Design for Manufacturing, Design Control, FDA, Product Design, ISO 13485, DMAIC, Product Development
Education
University of Michigan 2008 — 2009
Masters of Science Engineering, Mechanical Engineering
Michigan Technological University 2003 — 2007
Bachelors of Science, Mechanical Engineering
Undisclosed - Automotive Supplier June 2013 - Present
Terumo Cardiovascular Systems December 2012 - January 2013
Trijicon, Inc. April 2005 - April 2012
Sirius Satellite Radio 2000 - 2001
Rent-A-Center September 1988 - June 1999
John Hancock Life Insurance Company (U.S.A.) 1978 - 1984
Skills
Microsoft Word, PowerPoint, Customer Service, Social Media, Microsoft Excel, Microsoft Office, Internet, Program Management, Sales, Outlook, Continuous Improvement, Process Improvement, Retail Sales, Mary Kay Beauty..., Microsoft Outlook, Insurance
Education
Mott Community College
Associate of Arts / Associate of Applied Science, Child Development
Mott Community College
Associate of Applied Science
University of Michigan - Flint
Social Work
Terumo Cardiovascular Systems September 2010 - Present
Unemployed and looking for work January 2010 - September 2010
PESA Switching Systems, Inc. June 2008 - February 2010
QuStream March 2008 - June 2008
Jabil March 1999 - September 2007
Lucas Body Systems - TRW Automotive May 1998 - March 1999
Jabil January 1994 - May 1998
Jabil October 1993 - December 1993
AMP Interconnect Systems March 1993 - September 1993
Dow Chemical September 1987 - March 1993
Skills
PCB design, Altium Designer, Electronics, Schematic Capture, Engineering, Manufacturing, Orcad, Analog, Power Supplies, Design for Manufacturing, EDA, RF, Cadence, Board Layout, Allegro, Hardware Architecture, OrCAD, PCB Design
Education
Saginaw Valley State University 1978 — 1990
No Degree earned, Electrical Engineering, Biology
Cardinal Health May 2015 - Present
Terumo Cardiovascular Systems May 2014 - Present
Boston Scientific March 2012 - May 2014
Boston Scientific September 2009 - March 2012
Pfizer April 2007 - April 2009
Pfizer February 2006 - April 2007
Pfizer Pharmaceuticals August 1997 - February 2006
Skills
Sales, Coaching, Sales Management, Training, Customer Service, Sales Presentations, Cardiology, Recruiting, Account Management, Business Planning, Medical Devices, Product Launch, Pharmaceutical Sales, Selling, Cold Calling, Building Relationships, Cardiac..., Pacemakers, Defibrillator, Orthopedic, Cath Lab, Rheumatology, Operating Room, Sales Effectiveness, Sales Process, Managed Care, Urology, Leadership, Market Development, Surgeons, Healthcare, Sales Force Development, Capital Equipment, Pharmaceutical Industry, Selling Skills, Hospital Sales, Medical Sales, Diabetes, Disposables
Education
Oklahoma State University
Bachelor of Science, Business (Marketing)
CareFusion August 2014 - Present
BIOLASE August 2013 - August 2014
Ossur Americas January 2012 - July 2013
Alvarado Manufacturing March 2011 - January 2012
Fields Of Thunder Museum November 2010 - April 2011
Omnica Medical Device Product Development Co. March 2009 - November 2010
Terumo Cardiovascular Systems July 2008 - March 2009
FTM Machine & Design December 2004 - July 2008
Disney Corporation February 1999 - December 2004
AVC Medical Device Engineering / Consulting February 1992 - January 1999
Skills
Solidworks, Design for Manufacturing, R&D, Product Development, Manufacturing, Process Improvement, Project Management, Technical Documentation, Machine Design, CAD, Design Control, Product Design, Engineering, Mechanical Engineering, Medical Devices, Lean Manufacturing, Injection Molding, Electronics, Machining, Process Engineering, Continuous Improvement, Automation, Testing, FMEA, Rapid Prototyping, FDA, Machine Tools, ISO 13485, SPC, Manufacturing..., Design of Experiments, Engineering Management, Validation, Quality System, Materials, GD&T
Education
Saddleback College
Machine Technologies University 1972 — 1976
Mechanical engineering
Contuning Education Programs
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Medtronic August 2013 - Present
Covidien July 2011 - July 2013
St. Jude Medical February 2010 - July 2011
Disc Dynamics Inc July 2009 - December 2009
Disc Dynamics January 2008 - June 2009
Disc Dynamics November 2005 - December 2007
Disc Dynamics August 2004 - October 2005
Cordis, Johnson & Johnson April 2001 - July 2004
Terumo Cardiovascular Systems July 1997 - April 2001
Skills
ISO 13485, Six Sigma, Orthopedic, Spine, GMP, Cardiology, Electrophysiology, Medical Devices, Biomedical Engineering, Product Development, Continuous Improvement, Leadership, Design Control, FDA, Design of Experiments, CAPA, V&V, Quality System, Minitab, Quality Assurance, Root Cause Analysis, R&D, Cross-functional Team..., Lean Manufacturing, Catheters, Commercialization, Validation, ISO 14971
Education
University of Minnesota - Carlson School of Management 2010 — 2012
MBA, CEMBA (Carlson Excutive MBA Program)
Northwestern University 1996 — 1997
MS, Biomedical Engineering
University of Michigan 1992 — 1996
BS, Materials Science Engineering
Grosse Pointe South High School 1988 — 1992
OSTA June 2012 - Present
Terumo Cardiovascular Systems 2010 - June 2012
Skills
ISO 13485, FDA, Regulatory Affairs, CAPA, Medical Devices, GMP, Validation, Quality System, Regulatory Submissions, MDR, Recalls, V
Education
Northeastern University 2010 — 2012
Masters, Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of Massachusetts Boston 2008 — 2009
B.S., Biology
University of Massachusetts, Amherst 2007 — 2008
B.S., Biology
Ford Motor Company October 2013 - Present
Terumo Cardiovascular Systems March 2011 - October 2013
Terumo Cardiovascular Systems May 2009 - March 2011
Chrysler 2003 - 2008
Chrysler 2003 - 2008
Skills
Root Cause Analysis, FMEA, DFMEA, Engineering, Quality Assurance, CAPA, Quality Auditing, Medical Devices, SPC, PPAP, Design of Experiments, Quality System, DMAIC, Supplier Quality, Manufacturing..., Continuous Improvement, Six Sigma, Lean Manufacturing
Education
Oakland University 2004 — 2008
Master of Science (MS), Mechanical Engineering
Oakland University 1996 — 2002
Bachelor of Science (BS), Mechanical Engineering
Terumo Cardiovascular Systems March 2015 - Present
University of Michigan October 2013 - December 2014
Engineering World Health April 2013 - July 2013
University of Pennsylvania May 2012 - August 2012
Skills
Matlab, Labview, Solidworks, Microcontrollers, Soldering, NI LabVIEW, Biomaterials, C, COMSOL, PowerPoint, Research, Tissue Engineering, Assembly Language, Stata, Arduino, Electronic Circuit..., Microsoft Excel, Microsoft Word, Outlook, R, Cadence, Biomedical Engineering, Microsoft Office
Education
University of Michigan 2013 — 2014
Master of Science (MS), Bioengineering and Biomedical Engineering
University of North Carolina at Chapel Hill 2009 — 2013
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
North Carolina Agricultural and Technical State University 2010 — 2011
GE Transportation December 2013 - Present
Ryder Supply Chain Solutions December 2012 - December 2013
GE Transportation September 2011 - November 2012
University of Central Missouri August 2009 - August 2011
Terumo Cardiovascular Systems April 2009 - July 2009
Dicks Sporting Goods November 2008 - May 2009
Wayne State University August 2008 - December 2008
American Junior Golf Association May 2008 - August 2008
Great Lakes Intercollegiate Athletic Conference 2007 - 2007
Skills
Editing, Photography, Microsoft Office, PowerPoint, Microsoft Excel, Event Planning, Leadership, Research, Microsoft Word, Spanish, Customer Service, Data Management, ERP Oracle, InDesign
Education
University of Central Missouri 2009 — 2011
Master of Science 2011 Bachelor, Business Administration 2007; Athletic and Sports Business Administration
Northwood University 2003 — 2007
BBA, Sport and Entertainment Management/ Business Management
PRL!
Terumo Cardiovascular Systems February 2015 - Present
Thoratec July 2013 - January 2015
Terumo Heart Inc August 2012 - July 2013
Terumo Heart Inc October 2011 - August 2012
Bard Access Systems May 2006 - September 2011
Cardiovascular Research Institute May 2006 - January 2007
Flint Land Surveying March 1994 - May 2006
Skills
Medical Devices, Quality Systems, Biomedical Engineering, Product Design, FMEA, Quality Engineering, Six Sigma, Statistics, Product Development, Data Analysis, Design Control, Validation, Testing, Minitab, ISO 13485, Root Cause Analysis, CAPA, Quality Assurance, Analysis, Cross-functional Team..., Continuous Improvement, Quality System, Engineering, FDA, Lean Manufacturing, ISO 14971, Manufacturing, Quality Control, Team Management, Test Development, Development Testing, Cardiovascular..., Quality Management, SPC, Design of Experiments, R&D, 21 CFR, Design for Manufacturing, Biomaterials, Catheters, DMAIC, ISO, CQE, IEC 60601, GMP, V&V
Education
Southern Polytechnic State University 2008 — 2011
Masters of Science, Quality Engineering
University of Utah 2004 — 2007
Bachelors of Science, Biomedical Engineering
Validant September 2014 - Present
Alcon Laboratories, Inc. September 2013 - September 2014
Terumo Cardiovascular Systems June 2011 - August 2013
Johnson & Johnson June 2004 - May 2011
YSI January 2000 - June 2004
Skills
Medical Devices, Design Control, Design of Experiments, Biomedical Engineering, ISO 13485, R&D, V&V, Quality System, Design for Manufacturing, Validation, Engineering, FDA, ISO 14971, SolidWorks, Patents, Innovation, Labview, Microcontrollers, FPGA, C++, C#, Matlab, Statistics, Design Verification..., Combination Products, Functional Verification, Drug Delivery
Education
University of Dayton 2000 — 2002
MSME, Mechanical Engineering
University of Dayton 1997 — 2000
BSME, Mechanical Engineering
The Catholic University of America 1995 — 1997
BSME, Biomedical Engineering
Terumo Cardiovascular Systems June 2015 - Present
Aria Systems October 2014 - June 2015
Defense Language Institute August 2014 - October 2014
Seletive Granite and Marble June 2010 - July 2014
OT Cars October 2012 - December 2013
Roundtable Pizza February 2011 - November 2013
Skills
Computer Repair, Help Desk Support, Network Administration, Ghost Imaging, WiFi, Active Directory, DoD, Customer Service, Remote Troubleshooting, Mac OS, Windows, Windows 7, Windows XP, Windows 8, VMware, Virtualization, Virus Removal, VirtualBox, Network Security, Computer Security, SharePoint, OneDrive, Lync, Windows Server, Call Centers, Computer Hardware, Printers, Routers, Cisco Technologies, WebEx, Avaya Technologies, Ticketing, Outlook, Box.net, Dell Computers, Shared Storage, Apple Support, Apple Servers, Employee Training, Linux, Security
Education
MTI College 2011 — 2013
Associate's Degree, Information Technology
Medtronic Minimally Invasive Therapies Group July 2015 - Present
Smith & Nephew March 2015 - July 2015
Maquet Getinge Group September 2014 - March 2015
Johnson & Johnson (Depuy-Synthes) September 2013 - September 2014
Terumo Cardiovascular Systems September 2012 - October 2013
GE Healthcare Bio Process Corp. January 2007 - January 2008
L'Oreal USA Luxury Products Division August 2006 - October 2007
BD 2005 - 2006
Skills
Process Development, Quality Engineering, SAP, Process Validation, Process Flow, Risk Assessment, ISO 14001, ISO 10993, Clean Rooms, Statistical Data..., Lean Manufacturing, Team Building, Process Improvement, Process Management, Sterilization, Consent Decree, ISO 13485, V&V, Process Simulation, Quality Control, FDA, Validation, Engineering, Software Documentation, ISO, Medical Devices, Design of Experiments, Manufacturing, Sop, Quality System, FMEA, Design Control, CAPA, GMP, ISO 14971, SOP
Education
New Jersey Institute of Technology 2002 — 2006
Bachelor's degree, Chemical Engineering
University of Michigan 2013 — 2013
Six Sigma Green Belt, Manufacturing Engineering
O-I March 2015 - Present
Owens-Illinois September 2013 - March 2015
Terumo Cardiovascular Systems May 2013 - September 2013
University of Toledo January 2013 - May 2013
Dunbar Mechanical, Inc. May 2012 - September 2012
Duperon Corporation May 2011 - September 2011
Skills
Microsoft Office, Engineering, Solidworks, Mechanical Engineering, CAD, Matlab, Adobe Acrobat Pro, VSPC Shopfloor, Teamwork
Education
University of Toledo 2012 — 2014
BSME Undergraduate, Mechanical Engineering
Saginaw Valley State University 2010 — 2012
BSME Undergraduate, Mechanical Engineering
Terumo Cardiovascular Systems May 2015 - July 2015
University of Michigan-Dearborn September 2013 - May 2015
University of Michigan-Dearborn May 2012 - April 2015
Terumo Cardiovascular Systems May 2013 - August 2013
University of Michigan-Dearborn June 2012 - May 2013
Education
The George Washington University Law School 2015 — 2018
Juris Doctor (J.D.)
University of Michigan-Dearborn 2011 — 2015
Bachelor of Science (B.S.), Chemistry (ACS Certified), Biochemistry, with High Distinction
Deloitte March 2015 - Present
Johnson & Johnson June 2013 - December 2014
Terumo Cardiovascular Systems January 2013 - June 2013
SAP America June 2012 - December 2012
St. Jude Medical June 2011 - June 2012
GE Healthcare 2007 - June 2011
Abbott Labs January 2005 - May 2007
Skills
Computer System..., Compliance, FDA, GxP, QSR, 21 CFR Part 11, cGMP, GAMP, CAPA, ISO 14971, ISO 13485, Change Control, Quality Systems, Medical Devices, Validation, Software Validation, Quality Auditing, Software Quality..., Validations, Quality Management, Regulatory Requirements, Documentation, QC, Testing, Remediation, Life Sciences, Process Improvement, Process Control, Technical Writing, SAP, Quality System, GMP, Software Documentation, LIMS, SDLC, Documentum, User Acceptance Testing, Document Management, Test Planning, ERP, Quality Center, Project Management, Gap Analysis, Test Management, Sop, Cross-functional Team..., ISO, Pharmaceutical Industry, Program Management, Regulatory Affairs
Education
New York Institute of Technology
MBA, Managerial Information Systems
New York Institute of Technology-Old Westbury
Bachelor's
Terumo Cardiovascular Systems May 2014 - August 2014
Starlight Children's Foundation Australia May 2013 - July 2013
Lifetime Fitness May 2012 - August 2012
High Velocity Sports October 2010 - July 2012
Skills
Teamwork, Leadership, Nursing Care, Organization, Documentation, Microsoft Word, Soccer, Creativity Skills, Writing
Education
Ohio Northern University 2011 — 2015
Bachelor of Science (BS), Nursing
Terumo Cardiovascular Systems October 2011 - Present
Terumo January 2007 - September 2011
Skills
Design Control, ISO 13485, FDA, Design of Experiments, Quality System, Medical Devices, Root Cause Analysis, Product Development, Lean Manufacturing, Continuous Improvement
Education
Temple University - Fox School of Business and Management 2015 — 2019
Master of Business Administration (MBA)
University of Delaware 2003 — 2007
Bachelor of Science (BS), Mechanical Engineering
Terumo Cardiovascular Systems May 2014 - Present
Terumo Cardiovascular Systems July 2010 - May 2014
Foamade Industries March 2005 - March 2009
Foamade Industries September 2000 - March 2005
Foamade Industries January 2000 - September 2000
Foamade Industries January 1992 - January 2000
Skills
FMEA, Supplier Quality, Auditing, ISO 13485, TS16949, Supplier Performance, PPAP, Quality Metrics, Quality System, Root Cause Analysis, Manufacturing, APQP, Quality Control, Continuous Improvement, ISO/TS 16949, Lean Manufacturing, Quality Assurance, Quality Management
Education
Schoolcraft College
Information Technology
Michigan State University
BA, Telecommunications
Alere Inc. February 2014 - Present
Alere Inc. August 2013 - January 2014
Inova Diagnostics June 2011 - July 2013
Quidel December 2008 - June 2011
Beckman Coulter January 2007 - December 2008
Nanogen Inc June 2005 - December 2006
Alza Corp (Johnson and Johnson) September 2002 - May 2005
Siemens Healthcare (Formerly Acuson) January 2001 - September 2002
Affymetrix September 1998 - January 2001
Terumo Cardiovascular Systems January 1997 - May 1998
Skills
Design of Experiments, Manufacturing, Lean Manufacturing, FDA, Medical Devices, Validation, ISO 13485, Design Control, Quality System, V&V, CAPA, Biotechnology, GMP, ISO, Six Sigma, R&D, Process Simulation, Process Engineering, Sop, Quality Control, Lifesciences, Manufacturing..., Technology Transfer, Product Development, Pharmaceutical Industry, Quality Assurance, SPC, Testing, Engineering, ISO 14971, Root Cause Analysis, GLP, Commercialization, FMEA, Drug Delivery, Hardware Diagnostics, Quality Management, Protein Purification, Product Launch, Calibration, Continuous Improvement, Biomedical Engineering, Cross-functional Team..., Value Stream Mapping, Troubleshooting, Aseptic Processing, Chemistry, Supply Chain Management, Laboratory, Immunoassays
Education
University of California, San Diego - The Rady School of Management 2010 — 2012
MBA
University of California, Irvine 2008 — 2008
Certificate, Leadership and Management Program
The Johns Hopkins University 1991 — 1995
BS, Biomedical Engineering w/ Concentration in Chemical Engineering
Taipei American School 1988 — 1991
High School Diploma
Acclarent 2015 - 2015
Redbock February 2014 - September 2014
Black Diamond Networks January 2013 - December 2013
Reglera October 2012 - November 2012
Validant April 2012 - September 2012
Validant December 2011 - April 2012
Terumo Cardiovascular Systems 2012 - 2012
Generic Medical Devices, Inc. August 2009 - October 2011
Abbott Diagnostics August 2000 - November 2008
Johnson & Johnson Medical, Inc. August 1991 - August 2000
Skills
CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation, Design Control, V&V, GMP, Biotechnology, Regulatory Affairs, GLP, 21 CFR Part 11, Change Control
Education
Stephen F. Austin State University 1977 — 1980
B.S.
Terumo Cardiovascular Systems August 2012 - Present
The Catholic University of America August 2008 - May 2012
Army Research Laboratory June 2011 - August 2011
Skills
Biomedical Engineering, Engineering, Manufacturing, Matlab
Education
The Catholic University of America 2012 — 2013
Master of Biomedical Engineering, Biomedical/Medical Engineering
The Catholic University of America 2008 — 2012
Bachelor of Biomedical Engineering, Biomedical/Medical Engineering
C. Milton Wright High School
Terumo Cardiovascular Systems March 2012 - Present
Terumo Cardiovascular Systems November 2009 - March 2012
Creative Technology Services May 2005 - March 2009
TL Industries June 2004 - May 2005
Skills
Medical Devices, Manufacturing, Design Control, Surgical Instruments, ISO 13485, Microsoft Office, Non-Conforming, Scribe, Lean Manufacturing, Validation, Quality Assurance, Design of Experiments, GMP, ISO, Quality System, Continuous Improvement, SPC, CAPA, FDA, Program Management, Calibration, Root Cause Analysis, Quality Control, FMEA
Education
University of Phoenix 2014 — 2017
Bachelor's degree, Web Development, A
Monroe County Community College 2004 — 2005
Associates, Business Administration and Management, General
Bedford Senior High School 1996 — 1999
Tecomet Inc. August 2015 - Present
Truman Consulting, LLC January 2012 - Present
Terumo Cardiovascular Systems April 2015 - August 2015
Maquet Getinge Group August 2014 - April 2015
Maquet Getinge Group January 2014 - August 2014
Synthes June 2013 - October 2013
Phillips-Medisize April 2013 - June 2013
Millar Instruments, Inc. June 2012 - November 2012
Philips February 2012 - May 2012
St. Jude Medical August 2011 - February 2012
Skills
Extrusion, Packaging, Medical Devices, ISO 13485, Process Validation, Validation, Quality Systems, CAPA, Lean Manufacturing, Minitab, ISO, Design Control, Manufacturing, R&D, FMEA, Continuous Improvement, Process Development, Manufacturing..., GMP, Product Development, Quality Assurance, DMAIC, Root Cause Analysis, QSR, cGMP, Process Improvement, Kaizen, Injection Molding, V&V, Quality System, Process Simulation, FDA, Quality Control, Quality Auditing, Software Documentation, Engineering, Calibration, Design for Manufacturing
Education
Cardinal Stritch University 2010 — 2012
BS - Business Administration, BSM
University of St. Thomas 2004 — 2004
CPM, Project Management
North Hennepin Community College 2001 — 2003
Associate in Arts, General Studies
University of Minnesota-Twin Cities 1991 — 1993
General Studies
Robbinsdale Armstrong Senior High 1987 — 1989
Terumo Cardiovascular Systems November 2011 - Present
Terumo Cardiovascular Systems April 2008 - November 2011
Terumo Cardiovascular Systems April 2004 - April 2008
Terumo Cardiovascular Systems January 2001 - April 2004
DaimlerChrysler May 1999 - August 1999
Skills
Electrical Engineering, Medical Devices, Electronic Circuit..., Embedded Software, Design Control, System Development, Software Development, Hazard Analysis, FMEA, Verification, Validation, Quality System, FDA, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, Perforce, Rational DOORS, Altium Designer, Microsoft Office, Automation, Sensors, V&V
Education
Oakland University 1996 — 2000
Bachelor of Science (BS), Electrical Engineering, 3.75 GPA, Magna Cum Laude
General Motors June 2013 - Present
Terumo Cardiovascular Systems January 2011 - May 2013
University of Michigan May 2011 - December 2011
Oakland University May 2009 - July 2009
General Motors May 2008 - August 2008
Skills
Computational Fluid..., Finite Element Analysis..., Boundary Element Method, CATIA, MATLAB, Maple, Fortran, C, Requirements Management..., Version Control Tools..., NI LabVIEW, Digital Image..., NI Sound and Vibration..., Microsoft Office, ATD Specific Software
Education
University of Michigan 2010 — 2011
Masters of Science, Biomedical Engineering
Oakland University 2006 — 2010
Bachelors of Science, Mechanical Engineering, Biology (minor)
Terumo Cardiovascular Systems May 2011 - Present
Ethicon Biosurgery August 2009 - May 2011
Stryker April 2005 - August 2009
Skills
Surgeons, Operating Room, Capital Equipment, Disposables, Medical Devices, Neurosurgery, Surgical Instruments, Orthopedic, Urology, Market Development, Spine, OB/GYN, ENT, Product Launch, Cardiology, Vascular Surgery, Surgery, Sales Management, Interventional..., Medical Sales, Cath Lab, Cardiac Surgery, Operating Room Sales, Interventional Radiology, Vascular, Pharmaceutical Sales, Selling Skills, Sales Force Development, Global Marketing, Sales Effectiveness, Sales Operations, Cold Calling, Hospitals, Sales, Surgical Device Sales, General Surgery, Selling, FDA, Sales Process, Orthopedics
Education
North Carolina State University - College of Management 1997 — 2002
Bachelor of Science (BS), Apparel and Textiles
Terumo Cardiovascular Systems July 2013 - Present
Development Dimensions International December 2006 - July 2013
T-Systems March 2005 - December 2006
gedas, USA November 2003 - March 2005
Skills
Performance Management, Training & Development, 360 Feedback, Microsoft Office, SharePoint, Job Analysis, Applicant Tracking..., Virtual Training, HTML, HR Consulting, Training Delivery, Computer Hardware..., Behavioral Interviewing, Troubleshooting, Instructional Design, Assessment Center, Succession Planning, Employee Training, Organizational..., Employee Engagement, Training, Talent Management
Education
Oakland University 2007 — 2009
Master's degree, Training and Development
Oakland University 2002 — 2006
Bachelor of Science (B.S.), Management Information Systems
KES October 2013 - Present
New Star Lasers 2014 - 2014
New Star Lasers 2014 - 2014
New Star Lasers 2014 - 2014
Varian Medical Systems 2014 - 2014
Varian Medical Systems 2014 - 2014
Optovue October 2012 - October 2013
Terumo Cardiovascular Systems February 2011 - June 2012
KES July 2010 - February 2011
TUV SUD July 2008 - July 2010
Skills
Compliance R&D, &..., CFR 820/MDD DIRECTIVES, Computerised System..., Compliance Testing, IEC 60601, Collaterals,..., IEC62366 Usability &..., ISO 14971:Risk..., Regulatory Affairs, R&D, ISO 14971, Project Management, Quality System, Computer System..., IEC 60601, CFR, Compliance, Quality Assurance, Salary, Medical Devices, FDA, Testing, Cross-functional Team..., Quality Auditing, ISO, Software Documentation, Product Development, V&V, Iso 9000, Manufacturing, Quality Control, Validation, ISO 13485, CAPA, Management, Engineering, Process Improvement
Education
University Phoenix, Arizona 2002 — 2004
MBA, TECHNOLOGY MANAGEMENT
San Jose State University 1997 — 1998
Program Transverred, Electrical/Electronic Engineering
The Polytechnic, Ibadan 1984 — 1989
BSC., Physics & Electronic Engineering
DePuy Synthes Companies of Johnson & Johnson December 2013 - Present
Terumo Cardiovascular Systems August 2012 - November 2013
Mitralign June 2011 - June 2012
Medtronic Inc June 1994 - July 2009
Skills
Gage R&R, Process Validation, ISO 13485, FMEA, SPC, DMAIC, Minitab, Process Development, Design of Experiments
Education
Northeastern University 1986 — 1991
BS, Mechanical Engineering
HeartWare Inc March 2013 - Present
HeartWare Inc December 2010 - March 2013
Terumo Cardiovascular Systems July 2007 - December 2010
Ethicon Biosurgery July 1999 - June 2007
Skills
Medical Devices, Product Development, Cardiac Surgery
Education
Salem College 1995 — 1999
Bachelor of Arts (BA), Communication and Media Studies
Terumo Cardiovascular Systems February 2015 - June 2015
Fresenius Medical Care December 2014 - February 2015
Sarah Cannon Research Institute May 2014 - November 2014
Ambu A/S December 2013 - May 2014
Biocompatibles May 2013 - November 2013
Regeneron Pharmaceuticals September 2012 - March 2013
Amgen March 2012 - August 2012
Biomimetic Therapeutics March 2007 - January 2012
Boston Scientific April 2006 - March 2007
Biomimetic Therapeutics April 2006 - June 2006
Skills
Validation, V&V, GAMP, 21 CFR Part 11, Quality Assurance, Computer System..., ISO 14971, ISO 13485, GMP, Testing, Quality System, Quality Auditing, FDA, Risk Management, Medical Devices, Pharmaceutical Industry, Software Documentation, CAPA, SOP, ISO, Quality Control, FMEA, Auditing, EMA, ICH Guidelines, TGA, CMDCAS, Biotechnology, Change Control, Regulatory Affairs, Manufacturing, Life Sciences, Regulatory Requirements
Education
Rutgers University-New Brunswick 1992 — 1996
BS, Computer Science
Berlin Heart Inc November 2013 - Present
MBK Biomedical Consulting LLC August 2006 - Present
Sunshine Heart Incorporated January 2012 - November 2013
Berlin Heart Inc. April 2006 - January 2012
Terumo Cardiovascular Systems May 2006 - November 2006
Terumo Heart, Inc. December 2004 - May 2006
Medtronic October 2002 - December 2004
HeartStent June 2002 - October 2002
Abiomed August 2001 - September 2001
Artificial Heart - Univ Medical Ctr - Arizona December 1993 - August 2001
Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, Regulatory Affairs, Quality Assurance, PMA, Cardiology, Clinical Development, Biotechnology, Cross-functional Team..., Biomedical Engineering, CE marking, Healthcare, Hospitals, ISO 13485, Product Development, Product Launch, Quality System, Regulatory Submissions
Education
University of Phoenix 1998 — 2000
MBA, Healthcare Finance
Texas A&M University 1986 — 1993
BSBE, Bioengineering
Medtronic July 2012 - Present
Edwards Lifesciences April 2011 - July 2012
Terumo Cardiovascular Systems January 2009 - June 2011
Image Stream Medical April 2008 - December 2008
Stryker Endoscopy 2005 - 2008
US Surgical October 2004 - November 2005
Cisco WebEx 2000 - 2004
Skills
Medical Devices, Capital Equipment, Sales Management, Account Management, Consultative Selling, Selling, Cardiology, Critical Care, Cross-functional Team..., Operating Room, Product Launch, Orthopedic, Sales, Sales Operations, Salesforce.com, Surgeons, Surgery, Vascular
Education
San Diego State University-California State University 1992 — 1997
None 2011 - Present
Terumo Cardiovascular Systems March 2011 - July 2011
OptiMedica August 2008 - August 2010
Hospira June 2001 - August 2008
Tadiran Microwave Networks-Stafford TX. 1996 - 2001
C-COR COMLUX-Fremont, CA 1993 - 1996
PHASE TWO INDUSTRIES-Santa Clara, CA 1990 - 1993
DALMO VICTOR-Belmont, CA 1977 - 1990
TAB PRODUCTS-Palo Alto, CA 1970 - 1977
Skills
Telecommunications, Medical Devices, Design for Manufacturing, Manufacturing, Embedded Systems, R&D, Testing, PCB design, Electronics, Electrical Engineering, Fiber Optics, Product Development, Integrated Circuit..., Root Cause Analysis, Microcontrollers, Integration, Product Management, Hardware Architecture, FPGA, FDA, Validation, Engineering Management, Simulations
Education
Portland State University 1964 — 1969
Master of Science, Applied Science (Electrical Engineering)
Systems Engineering Global Inc. SDB M/WBE June 2005 - December 2013
Terumo Cardiovascular Systems 2011 - 2013
Raytheon June 1998 - June 2005
Skills
FPGA using VHDL, Xilinx Development Tools, DOORS, ModelSim, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Project, Microsoft Power Point, Visio, Systems Engineering, Simulations, Digital Signal..., Functional Verification, Electronics, System Design, FPGA, VHDL, System Architecture, Firmware, Testing, Manufacturing, Engineering, Embedded Systems, Electrical Engineering, Linux, Requirements Analysis, Management, C++, Avionics, Labview, Semiconductors, Requirements Management, Embedded Software, Telelogic DOORS, Aerospace, Technical Leadership
Education
The Johns Hopkins University 2002 — 2004
Master of Science (M.S.), Systems Engineering, 4.0 GPA
NC A & T State University 1991 — 1995
Bachelor of Science (BS), Electrical Engineering, Magna Cum Laude
Wake Technical Community College 1989 — 1991
Associate of Applied Science, Electronics Engineering Technology
Terumo Cardiovascular Systems November 2014 - Present
Invacare November 2011 - November 2014
Amylin Pharmaceuticals May 2011 - December 2011
Covidien February 2009 - May 2011
Cook Biotech September 2004 - February 2009
Professional Integrated Services June 2000 - August 2004
Skills
Medical Devices, Quality Assurance, Quality System, Validation, Management, ISO 13485, FDA, CAPA, Quality Auditing, 21 CFR Part 11, Quality Control, Computer System..., Minitab, GxP, 21 CFR, Regulatory Requirements, Product Launch, GMP, Design Control, Change Control, Regulatory Affairs, Operational Excellence, ISO, ISO 14971, Leadership, Sop, Root Cause Analysis, FDA GMP, V, Cross-functional Team..., Process Improvement, Lean Manufacturing, Continuous Improvement, Manufacturing, Quality Management, Six Sigma, V&V, DMAIC, FMEA, Biotechnology, Problem Solving, Pharmaceutical Industry
Education
Purdue University 2005 — 2007
Science, Organizational Management
InterAmerican University 1991 — 1995
Bachelor of Business Administration (BBA), Business
Terumo Cardiovascular Systems September 2013 - Present
Terumo Cardiovascular Systems June 2012 - September 2013
Terumo Cardiovascular Systems May 2009 - June 2012
Terumo Cardiovascular Systems April 2005 - May 2009
Toledo Molding and Die January 2003 - April 2005
Wood County Hospital April 2002 - January 2003
Skills
Medical Devices, Quality System, FDA, ISO 13485, Technical Writing, Validation, Quality Assurance, CAPA, Engineering, Six Sigma, Management, Root Cause Analysis, Training, Cross-functional Team..., Project Management, FMEA, Process Improvement
Education
University of Phoenix 2006 — 2008
BS, Business Management
Owens Community College 2003 — 2005
American Sign Language
Terra Community College 2000 — 2001
Social Work
Terumo Cardiovascular Systems October 2014 - Present
Terumo Cardiovascular Systems April 2013 - September 2014
Aastrom Biosciences April 2012 - April 2013
Terumo Cardiovascular Systems March 2008 - April 2012
Terumo Cardiovascular Systems March 2005 - 2008
Unisys March 2000 - March 2005
Packard Bell NEC 1997 - 1998
Skills
Medical Devices, Quality System, Cross-functional Team..., FDA, Manufacturing, Supply Management, Product Development, Continuous Improvement, Strategic Sourcing, Lean Manufacturing, Process Improvement, ISO 13485, Root Cause Analysis, Sourcing, Supply Chain Management, Design Control, Quality Assurance, FMEA, Validation, Purchasing
Education
New Mexico State University 1989 — 1992
Bachelor, Production and Operations Management
Oslo and Akershus University College 1983 — 1985
Associate's, Math & Physics
Roper Hospital 2009 - 2010
Terumo Cardiovascular Systems January 2006 - September 2008
Guidant 2000 - 2006
Guidant 2002 - 2003
Duke University Medical Center 1997 - 2000
Mayo Clinic 1996 - 1997
Education
Midwestern University (IL) 2004 — 2006
Texas A&M University at Galveston 1987 — 1991
BS, Marine Transportation
Medline Industries July 2013 - Present
MEDISISS January 2011 - December 2012
Teleflex May 2010 - January 2011
Multiple Companies November 2008 - May 2010
Terumo Cardiovascular Systems April 2005 - November 2008
Teleflex Incorporated March 2003 - April 2005
Surgical Principals February 2002 - March 2003
Aesculap October 1998 - February 2002
Pfizer August 1997 - October 1998
Harrison Medical Center June 1989 - August 1997
Skills
Medical Devices, Capital Equipment, Operating Room, Surgeons, Disposables, Orthopedic, Surgical Instruments, Cardiology, Urology, Sales Management, Surgery, Vascular, Hospitals, Interventional Radiology, Interventional..., New Business Development, Cath Lab, Sales Operations, OB/GYN, General Surgery, ENT, Sales Process
Education
Olympic College
US Navy Hospital Corpsman
Technician
US Navy Otolaryngology Technician
Toriner May 2015 - Present
Terumo Cardiovascular Systems September 2014 - February 2015
Alere, Inc. September 2013 - August 2014
St. Jude Medical January 2013 - August 2013
Volcano Corporation March 2012 - January 2013
Ethicon Endo-Surgery June 2011 - March 2012
Devicor Medical Products December 2010 - April 2011
NuVasive June 2009 - July 2010
Victor Clinical Corporation December 2003 - June 2009
Medtronic July 2002 - December 2003
Skills
Class III Medical..., Risk Management, Clinical Trials, Quality Systems, CAPA, Quality Assurance, Change Management, FDA, NCR, Quality System, Medical Devices, Design Control, ISO 13485, Validation, R&D, Testing, ISO 14971, Change Control, Product Development, FMEA
Education
South Dakota School of Mines and Technology 1981 — 1984
BS, Electrical Engineering
University of Minnesota-Twin Cities 1975 — 1977
BS, Mortuary Science
The University of South Dakota 1971 — 1975
General coursework
Gettysburg High School
Terumo Cardiovascular Systems April 2014 - Present
Synthes August 2013 - April 2014
Terumo Cardiovascular Systems August 2012 - August 2013
Johnson & Johnson July 2011 - August 2012
Stryker Instruments November 2009 - November 2010
Zimmer March 2009 - November 2009
Teleflex March 2008 - December 2008
Accellent October 2007 - February 2008
Boston Scientific 2006 - 2007
Skills
Quality Assurance, FDA, ISO 13485, Manufacturing, Validation, Change Control, V&V, Quality System, Auditing, Computer System..., Quality Auditing, Design Control, Quality Control, Cleaning Validation, Process Improvement, ISO, Medical Devices, CAPA, Sop, 21 CFR Part 11, GxP, GMP
Education
Villanova University 2009 — 2009
Certificate, Lean Six Sigma Black Belt
Stony Brook University 1989 — 1995
BS, Biology
Villanova University
Certificate, Six Sigma Green Belt
Toyoda Gosei October 2014 - Present
Toyoda Gosei April 2012 - November 2014
Terumo Cardiovascular Systems October 2011 - March 2012
Terumo Cardiovascular Systems October 2010 - November 2011
Terumo Cardiovascular Systems January 2010 - October 2010
General Motors October 2008 - January 2010
General Motors October 2006 - October 2008
Skills
Continuous Improvement, FMEA, Quality System, Manufacturing, ISO 13485, Lean Manufacturing, Purchasing, Six Sigma, Root Cause Analysis
Education
Oakland University 1997 — 2004
BSME, MSME, MBA, Mechanical Engineering, Marketing/Supply Chain Management
Forest Laboratories October 2011 - Present
OnSite Research August 2001 - Present
Teva Pharmaceuticals September 2010 - 2012
Terumo Cardiovascular Systems December 2007 - August 2010
Orthovita July 2005 - July 2009
Fujirebio Diagnostics, Inc. 2007 - 2008
Quintiles Inc. May 1998 - August 2000
Skills
Clinical Trials, Immunology, Bioequivalence, Asthma, Central Nervous System, Internal Medicine, Digital Imaging, GCP, CTMS, Clinical Research, Oncology, CRF design, Regulatory Affairs, Regulatory Submissions, Clinical Development, Medical Devices, FDA, CRO
Education
Ohio University 1986 — 1990
BS, Zoology/Biology
Terumo Cardiovascular Systems August 2007 - Present
Quest Medical 2004 - 2007
Skills
Medical Devices, Capital Equipment, Sales Force Development, Account Management, Product Launch, Healthcare, Hospitals, Product Marketing, Sales Management, New Business Development, Marketing Strategy, Selling Skills, Disposables, Cardiology, Surgeons, Operating Room, Orthopedic
Education
Texas Tech University 1996 — 2000
Bachelor Degree, Human Sciences
Springlake Earth High School 1992 — 1996
Terumo Cardiovascular Systems July 2010 - Present
Acorn Industries June 2009 - July 2010
Cytotech Labs LLC October 2007 - July 2009
Double Eagle Steel Coating Company August 2007 - October 2007
Master Chemical Corporation March 2007 - August 2007
Amcor August 2006 - February 2007
Superior Sorting LLC March 2006 - August 2006
BioPort Corporation March 2005 - March 2006
Ash Stevens Inc. March 2001 - March 2003
Coca-Cola Enterprises June 1998 - February 2001
Skills
GMP, Quality Assurance, Quality System, CAPA, Validation, Sop, Pharmaceutical Industry, FDA, Regulatory Affairs, Change Control, 21 CFR Part 11, GLP, V&V, GxP, Quality Management, Quality Auditing, Medical Devices, GCP, Computer System..., Biotechnology, Auditing, Consulting, HPLC, GC-MS, GC, ISO 14644, ISO, USP, 21CFR 210 & 211, 21 CFR 820 (QSR), Database Administration
Education
Northcentral University 2012 — 2015
PhD Doctoral Candidate, Organizational Leadership, 3.9
Spring Arbor University 2005 — 2007
Master's degree, Organization Management
Spring Arbor University 1985 — 1989
Bachelor's degree, Biochemistry
Terumo Cardiovascular Systems August 2008 - Present
Johnson Matthey Inc March 2007 - August 2008
Clinical CONNEXION September 2006 - January 2007
Clinical CONNEXION January 2005 - September 2006
Clinical CONNEXION January 2003 - December 2004
Clinical CONNEXION April 2002 - January 2003
Cytocom, LLC August 2001 - April 2002
Skills
Employee Benefits, Employee Relations, Recruiting, Training, Benefits Administration
Education
Monmouth University 1997 — 2001
BS, Marketing/Communications
St. Jude Medical Contract Quality EngineerSt. Jude NeromodulationAugust 2011 - April 2012
Terumo Cardiovascular Systems September 2010 - August 2011
Terumo Cardiovascular Systems November 2008 - September 2010
General Motors December 2005 - November 2008
General Motors September 1999 - November 2005
General Motors August 1999 - September 1999
General Motors December 1995 - July 1997
Skills
ISO 13485, ISO 14971, Fault Tree Analysis, FMEA, Vehicle Testing, Validation, Corrective Action, Quality Management, CAPA, Root Cause Analysis, FDA, Quality Assurance, Medical Devices, Quality System, Manufacturing, V&V, Design Control, Design of Experiments, Six Sigma, Quality Control, Cross-functional Team..., ISO
Education
Purdue University 2000 — 2004
MSE, QRD (Quality, Reliability, Dependability)
The University of New Mexico 1989 — 1994
BSME, Engineering
Terumo Cardiovascular Systems November 1997 - Present
Education
Providence College 1981 — 1985
BS, Health Administration
ForSight VISION5 February 2015 - Present
Teleflex Incorporated February 2014 - December 2014
Volcano Corporation April 2013 - December 2013
Terumo Cardiovascular Systems October 2012 - April 2013
Medtronic January 2012 - October 2012
Abbott Vascular April 2011 - October 2011
Conor Medsystems (Cordis) June 2009 - May 2011
Alexza Pharmaceuticals 2007 - 2009
Cepheid 2005 - 2007
Advanced Bionics January 2005 - December 2005
Skills
Solidworks, Cobalt, Machining, Medical Devices, R&D, Manufacturing, Diagnostics, GLP, Validation, V&V, FDA, Design Control, ISO 13485, Six Sigma, Quality System, FMEA, Hardware Diagnostics, SPC, SolidWorks
Education
San Jose State University
M.S., Chemical Engineering
Oregon State University
B.S., Chemical Engineering
University of Oregon
B.S., Biology, Chemistry
Terumo Cardiovascular Systems Quality Control3M Healthcare Medical DevicesMay 2004 - May 2006
Education
Tennessee State University 1996 — 2000
B.S, Chemistry
Stryker Instruments September 2009 - Present
Terumo Cardiovascular Systems 2012 - 2015
Terumo Cardiovascular Systems 2012 - 2015
Terumo Cardiovascular Systems 2012 - 2015
Terumo Cardiovascular Systems 2012 - 2015
Terumo Medical 2012 - 2013
Loc Performance Products May 2008 - February 2009
Aerotek/ Chrysler March 2005 - May 2008
Chrysler 2005 - 2008
Integrated Manufacturing 2002 - 2004
Skills
Automotive, APQP, Quality Engineering, Supplier Quality, Process Engineering, Cost Estimating, Continuous Improvement, Manufacturing, GD&T, FMEA, PPAP, Lean Manufacturing, Operations Management, ISO 13485, Quality Systems, Process Improvement, Program Management, Medical Devices, Quality System, DFMEA, SPC, Root Cause Analysis, Manufacturing..., ISO, Engineering Management, Injection Molding, Value Stream Mapping, DMAIC, Design for Manufacturing, Design Control, Kaizen, CAPA, Design of Experiments, Process Capability, V&V, Six Sigma, Quality Management, Quality Control, Geometric Dimensioning...
Education
Northern Michigan University
BS Business Administration, Accounting and mechanical engineering
Terumo Cardiovascular Systems September 2010 - Present
Courier Corporation September 2009 - September 2010
Callaway Golf 2006 - 2009
Skills
Six Sigma, Lean Manufacturing, Validation, Verification, Work Instructions, Root Cause Analysis, Complaint Investigations, Continuous Improvement, Design of Experiments, Value Stream Mapping, Test Method Validation, ISO 13485, Minitab, Quality System, Binary Optimization, Manufacturing..., DMAIC, SPC
Education
Northeastern University 2004 — 2009
Bachelor of Science (B.S.), Industrial Engineering
Haemonetics October 2014 - Present
Haemonetics January 2013 - October 2014
Terumo Cardiovascular Systems May 2011 - January 2013
Terumo Cardiovascular Systems August 2009 - May 2011
Walker Parking Consultants July 2007 - October 2008
Voxware May 2006 - September 2006
Voxware January 2005 - June 2005
Administrative Office of the Trial Court - Court Capital Projects January 2004 - June 2004
Skills
Manufacturing, Six Sigma, Quality System, Cross-functional Team..., Medical Devices, Root Cause Analysis, FDA, ISO 13485, Process Improvement, Lean Manufacturing
Education
Northeastern University 2002 — 2007
Bachelor of Science, Industrial Engineering
Ford Motor Company September 2012 - Present
Terumo Cardiovascular Systems July 2012 - September 2012
Auto Alliance Inc (MazdaNAO/Ford Motor Company) August 2011 - July 2012
C R England July 2010 - August 2011
Behr America, Inc. August 2004 - February 2009
Visteon Automotive Systems February 2001 - January 2004
Delphi Automotive Systems February 1995 - February 2001
Valeo Thermique Habitacle March 1993 - March 1995
Skills
Automotive, FMEA, DFMEA, Lean Manufacturing, Six Sigma, PPAP, Root Cause Analysis, Manufacturing..., Manufacturing, APQP, GD&T, SPC, Continuous Improvement, Supplier Quality, Product Design, Engineering Management, HVAC, Engineering, Injection Molding, Vehicles, Quality System, Cross-functional Team..., Powertrain, Process Improvement
Education
State University of New York College at Buffalo 1996 — 2000
MBA, Finance
The University of Kansas 1982 — 1988
BS, Mechanical Engineering
The University of Kansas 1982 — 1988
BA, Slavic Languages & Literature (Russian)
Terumo Cardiovascular Systems October 2010 - Present
Terumo Cardiovascular Systems 2008 - October 2010
Terumo Cardiovascular Systems 2003 - 2008
Terumo Cardiovascular Systems 1998 - 2003
Terumo Cardiovascular Systems 1997 - 1998
Terumo Cardiovascular Systems 1995 - 1997
Skills
Six Sigma, Lean Manufacturing, Quality Assurance, CAPA, Validation, SPC, FMEA, ISO 13485, Manufacturing, Medical Devices, Design of Experiments, Quality Auditing, Product Development, Leadership, Management, Quality System, FDA, Continuous Improvement, Root Cause Analysis, Statistics, Customer Presentations, Production Line..., New Product Line Start..., ISO 14971, DMAIC
Education
New York Institute of Technology 2004 — 2006
MBA, Business Administration
University of Delaware 1984 — 1990
Bachelor of Science (BS), Business Administration, Management and Operations
Vistakon January 2015 - Present
ConMed October 2013 - January 2014
Hospira March 2013 - August 2013
Terumo Cardiovascular Systems March 2012 - March 2013
St. Jude Medical, Neuromodulation Div. September 2011 - December 2011
Eos Energy Storage, LLC May 2011 - August 2011
Lehigh University September 2007 - April 2010
OraSure Technologies 1998 - 2003
BD 1992 - 1995
Baker Instruments 1978 - 1990
Skills
Medical Devices, FDA, Quality Assurance, Validation, R&D, V&V, Solidworks, Manufacturing, Design for Manufacturing, Quality Control, Hardware Diagnostics, Injection Molding, Chemistry, Automation, CAPA, Design Control, Design of Experiments, ISO 13485
Education
Stevens Institute of Technology 1966 — 1973
MS, Medical Engineering (Mechanical Eng)
Soaring Hearts Inc April 2004 - Present
Terumo Cardiovascular Systems July 1999 - January 2004
Skills
Cardiovascular Devices, Private Pilot, Biomedical Engineering, Clinical Engineering, ISO 14971, ISO 13485, Design Control, Medical Devices, Biomaterials, Biocompatibility, Capital Equipment, Biomedical Devices, 21 CFR, Tissue Engineering, CE marking, Bioengineering, Medical Device Directive
Education
University of Phoenix 2003 — 2005
Master of Business Administration (MBA), Cardiovascular Science, A
Southern Illinois University, Carbondale 1994 — 1997
Bachelor of Science (BS), Electrical and Electronics Engineering
MJB Engineering, LLC. June 2009 - Present
Triumph Group January 2013 - November 2013
MJB Engineering, LLC April 2011 - January 2013
Terumo Cardiovascular Systems August 2010 - April 2011
BAE Systems July 2008 - June 2009
Smiths-Medical 1265 Grey Fox October 2006 - July 2008
Honeywell DESE March 2006 - September 2006
Medtronic November 2005 - February 2006
Honeywell Labs October 2004 - November 2005
Pakon, Inc February 2004 - July 2004
Education
Anoka Ramsey Community College
Req. BA, Electrical Engineering
Saint John's University
Masters, Divinity
U.S. Navy - Basic Electrical & Electronics (BEE)
BA, Electrical Engineering
University of Minnesota-Twin Cities
Masters, Electrical Engineer
•U.S. Navy - Radio/Radar Electronics (ETA)
BA, Electrical Engineering
Terumo Cardiovascular Systems August 2014 - Present
ConvaTec March 2013 - July 2014
ConvaTec July 2008 - February 2013
ConvaTec March 2006 - June 2008
ConvaTec March 2001 - February 2006
Skills
Surgeons, Wound Care, Operating Room, Disposables, Medical Devices, Medical Sales, Orthopedic, Sales Effectiveness, Surgery, Hospitals, Capital Equipment, Urology, Vascular, Market Development, Sales Operations, OB/GYN, Nursing, Sales Management, Neurosurgery, Sales Process, Spine, Cardiology, Physicians, Surgical Instruments, Interventional Radiology, Healthcare, Clinical Research, Product Launch, Hospital Sales, General Surgery, Strategy, Sales
Education
Newberry College
B.A., Sociolgy
St. Petersburg College
A.S., Nursing
Terumo Cardiovascular Systems October 2009 - Present
Terumo Cardiovascular Systems November 2005 - October 2009
Terumo Cardiovascular Systems November 2001 - November 2005
Skills
Disposables, Vascular, Medical Devices, Cardiology, Market Development, Capital Equipment, Sales, Product Marketing, Management, Key Account Management, Cardiothoracic Surgery, Contract Negotiation, Cardiac Surgery, Hospitals, Operating Room, Interventional...
Education
Providence College 1981 — 1985
BS, Health/Health Care Administration/Management
*Confidential* 2013 - Present
Terumo Cardiovascular Systems August 2010 - September 2013
Maquet Cardiovascular January 2008 - July 2010
Ortho McNeil Pharm September 2006 - January 2010
ETHICON, INC January 1998 - January 2006
Ethicon 1990 - 2006
J & J January 1992 - January 1996
J & J January 1990 - January 1994
Levolor January 1987 - 1990
Levolor January 1984 - January 1987
Skills
Lean Manufacturing, Process Improvement, Six Sigma, Leadership, Manufacturing, Process Engineering, Product Development, 5S, ISO, Medical Devices, FDA, Management, Project Planning, Engineering, Budgets, Manufacturing..., Start-ups, Quality System, ISO 13485, Cross-functional Team..., Product Launch
Education
University of Arizona 1989 — 2001
MBA finance, finance / mgt
The College of New Jersey 1979 — 1983
Bachelor of Science (BS), Engineering
Terumo Cardiovascular Systems May 2015 - Present
Education
University of Florida
Master's Degree, Physician Assistant Studies
The University of Georgia
Bachelor's Degree, Biology, General
Caterpillar Inc. November 2014 - Present
Cambric Corporation September 2014 - Present
Terumo Cardiovascular Systems April 2014 - July 2014
Texas A&M University-Kingsville September 2012 - December 2013
Texas A&M University-Kingsville September 2011 - December 2013
Skills
Solidworks, Catia, Mechanical Engineering, Unigraphics, Pro Engineer, Matlab, Engineering, Finite Element Analysis, ANSYS, C, Fluid Mechanics, Abaqus, AutoCAD, CAD, Heat Transfer, Simulations, Six Sigma, SolidWorks, Solid Edge, Simulink, GD&T, Manufacturing, CATIA, PTC Creo, NX Unigraphics, Geometric Dimensioning...
Education
Texas A&M University-Kingsville 2011 — 2013
Master of Science (M.S.), Mechanical Engineering, 3.90 out of 4.0
Osmania University 2006 — 2010
Bachelor of Engineering (B.E.), Mechanical Engineering, 3.80 out of 4.0
J & J Vistakon February 2015 - August 2015
Atrium Medical April 2014 - January 2015
Microspec Corporation October 2013 - April 2014
Stryker January 2013 - September 2013
Terumo Cardiovascular Systems 2012 - 2013
St Jude Medical 2011 - 2011
Orthofix 2010 - 2011
Benchmark Electronics August 2004 - May 2010
Celestica January 2000 - January 2004
iRobot January 1999 - January 2000
Skills
QSR, Test, Complaints Management, Linux, ISO 13485, Medical Devices, FMEA, V&V, FDA, Root Cause Analysis, Six Sigma, Validation, SPC, Minitab, Manufacturing..., Quality System, Electronics, Testing, Continuous Improvement
Education
Southern New Hampshire University 2002 — 2004
MBA, Business
IT Management Daniel Webster College 1997 — 1999
BS, BSMIT
South Plains College
ASEE, Technology
Terumo Cardiovascular Systems September 2010 - Present
Honeywell January 2009 - August 2010
US Army May 2000 - May 2005
Skills
Electronics, Manufacturing, C++, Troubleshooting, Python, Visual Basic, Engineering, Testing, Labview, Electrical Engineering
Education
Northern Michigan University 2005 — 2008
Bachelor of Arts (B.A.), Electrical Engineering Technologies/Technicians
HeartWare Inc September 2014 - Present
Fresenius Medical Care December 2013 - August 2014
Synthes/Depuy August 2013 - December 2013
Terumo Cardiovascular Systems March 2012 - March 2013
Terumo Cardiovascular August 2010 - January 2012
Terumo Cardiovascular Systems August 2010 - July 2011
Medtronic May 2010 - August 2010
GE Healthcare April 2007 - May 2010
AT&T/Lucent Technologies January 1993 - January 2001
Skills
CAPA, Quality System, FDA, Quality Assurance, Medical Devices, Quality Control, Quality Auditing, Root Cause Analysis, ISO 13485, Auditing, Process Improvement, Manufacturing, Research, Training, Testing, Software Documentation, Regulatory Affairs, Internal Communications, Technical Writing, Six Sigma, Database Admin, Continuous Improvement, Writing, Project Management, Team Leadership, Database Management, Document Control, Document Management
Education
University of Phoenix 2004 — 2007
M.A, Adult Education
Southern Nazarene University 1995 — 1996
B.S, Management of Organizational Leadership
GE Healthcare 2015 - Present
Terumo Cardiovascular Systems 2011 - 2015
SonoSite 2011 - 2011
Ferring Pharmaceuticals 2006 - 2011
ADP 2004 - 2006
Vector Marketing 2002 - 2004
Skills
Urology, Sales Operations, Hospitals, Selling, Orthopedic, Medical Devices, Direct Sales, Sales, Sales Management, Account Management, Oncology, Pain Management, Surgery, Buy & Bill, Product Launch, Orthopedics, Pharmaceutical Sales
Education
St. Olaf College 1998 — 2002
B of A, Psychology
St. Olaf College 1998 — 2002
Bachelor of Arts, Psychology
New Trier 1994 — 1998
Bionostics February 2014 - Present
Terumo Cardiovascular Systems August 2012 - February 2014
Sekisui Diagnostics, LLC August 2011 - August 2012
Kaztronix September 2010 - September 2011
AlliedBarton Security Services February 2004 - February 2010
Mount Wachusett Community College 2006 - 2010
Sonoco 2004 - 2010
Skills
Microsoft Excel, Microsoft Office, GMP, Process Improvement, PowerPoint, FDA, Microsoft Word, Employee Training, Team Building, Security, Quality Assurance, Software Documentation, Technical Writing, Quality System, Sop, Medical Devices, Biotechnology, Outlook, GLP, Laboratory, Quality Control, CAPA, Change Control, ISO 13485, Training, Leadership, Troubleshooting, Manufacturing, Continuous Improvement, Program Management, Management, Team Leadership, SOP
Education
Mount Wachusett Community College 2008 — 2010
Associates in Science, Biotechnology/Biomanufacturing
oakmont regional high school 1994 — 1999
High School Diploma, High School/Secondary Diplomas and Certificates
Terumo Cardiovascular Systems July 2010 - Present
Education
Oakland University 2007 — 2011
BSME, Mechanical Engineering
Terumo Cardiovascular Systems June 2014 - Present
HELLA July 2013 - May 2014
A123 Systems June 2011 - July 2013
TRW Automotive February 2008 - May 2011
Chrysler January 2000 - January 2008
Skills
Engineering Management, R&D, Process Engineering, Manufacturing, FMEA, Test Equipment, Engineering, HEV, Automotive, Six Sigma, Kaizen, Catia, SPC, CAE, Aerospace, Vector CANalyzer, Vehicles, Product Design, Electronics, Cross-functional Team..., Root Cause Analysis, Matlab, GD&T, Powertrain, Automotive Engineering, Lean Manufacturing, PPAP, Continuous Improvement, DFMEA, DMAIC, Design of Experiments, Embedded Systems, Electrical Engineering, Electric Vehicles, Systems Engineering, Quality Management, Automotive Electronics, Finite Element Analysis, CANoe, APQP, Quality System, Manufacturing..., Testing, Product Engineering, PFMEA, Program Management, Product Development, Data Acquisition, Batteries, Value Stream Mapping
Education
Oakland University 2000 — 2001
Master of Science, Mechanical Engineering
University of Michigan 1994 — 1999
Bachelor of Science, Aerospace Engineering
Independent Consultant December 2014 - Present
Martinrea International July 2007 - 2008
Terumo Cardiovascular Systems 2006 - 2007
Amcor Rigid Plastics 1987 - 2003
Skills
Continuous Improvement, ISO, Injection Molding, Customer Service, Lean Manufacturing, Manufacturing, Packaging, Plastics, Product Design, Quality System, SPC, Management, 5S
Education
Schoolcraft College, Washtenaw Community College and University of Toledo 1997 — 2002
Plastics and Polymer Engineering Technology/Technician
Schoolcraft College 1993 — 1994
Certification, SPC
Terumo Cardiovascular Systems July 2012 - Present
Lycoming Engines July 2005 - May 2011
Proplastix International March 2005 - May 2005
Federal Mogul Corporation July 2000 - March 2004
West Pharmaceutical Services January 1986 - July 2000
Skills
Lean Manufacturing, Six Sigma, FMEA, DMAIC, Continuous Improvement, Root Cause Analysis, Kaizen, 5S, Value Stream Mapping, Injection Molding, Manufacturing, Supplier Quality, Minitab, Toyota Production System, Kanban, Green Belt, Manufacturing..., Process Improvement, Quality System, GD&T, Automotive
Education
Pennsylvania College of Technology (Affiliate of Pennsylvania State University) 1995 — 1999
B. S, Technology Management
Pennsylvania College of Technology 1995 — 1998
B. S, Plastics and Polymer Engineering Technology
Terumo Cardiovascular Systems February 2012 - Present
Quicken Loans October 2011 - January 2012
Ruby Tuesday Inc September 2004 - October 2011
Kroger August 2002 - September 2004
Education
Gibbs High School
High School Diploma
Pellissippi State Community College
Terumo Cardiovascular Systems November 2010 - Present
Factotem, Inc 2005 - Present
Terumo Cardiovascular Systems April 2009 - November 2010
Aastrom Biosciences January 2004 - July 2005
Bauer Controls July 2000 - January 2004
Sarns/3M Healthcare January 1989 - July 2000
Ethicon Endo-Surgery January 1987 - December 1988
Skills
Medical Devices, Business Analysis, FDA, ISO 13485, Validation, Quality Assurance, Quality System, Product Development, Process Improvement, Testing, Engineering, Manufacturing, Analysis, Cross-functional Team...
Education
Northwestern University 2012 — 2015
Master of Science (MS), Predictive Analytics
University of Michigan 1982 — 1986
Bachelor of Science (BS), Materials Science Engineering
Terumo Cardiovascular Systems July 2014 - Present
CIRTEC Medical Systems August 2007 - July 2014
Integra LifeSciences September 2006 - August 2007
Boston Scientific May 2005 - September 2006
Siemens Hearing Instruments, Inc. December 1999 - May 2005
Skills
Biomedical Engineering, Design for Manufacturing, Design Control, CAPA, Engineering, FDA, ISO 13485, Manufacturing, Manufacturing..., Medical Devices, Quality System, R, V, Validation, V&V, Design of Experiments, R&D
Education
Rutgers University 1999 — 2001
BS, Industrial and Process Engineering
NA
NA
Terumo Cardiovascular Systems July 1991 - Present
Education
Montclair State University
Bachelor of Arts (B.A.) & MBA
Blue.Point LLC June 2015 - Present
Blue.Point LLC November 2013 - June 2015
CaseStack June 2012 - November 2013
Syracuse University Carrier Dome January 2011 - May 2012
Goulds Pumps June 2011 - August 2011
Terumo Cardiovascular Systems June 2010 - August 2010
Skills
Consolidation, Supply Chain Management, Supply Chain, Warehousing, Logistics, Life Coaching, Inventory Management, World Class Customer..., Logistics Management, Forecasting, Analysis, SAP, Customer Service
Education
Syracuse University - Martin J. Whitman School of Management 2008 — 2012
Logistics, Materials, and Supply Chain Management
Terumo Cardiovascular Systems June 2015 - Present
Skills
ANSYS, C++, Mechanical Engineering, Microsoft Office, Microsoft Excel, SolidWorks, AutoCAD, Pro Engineer, Minitab, C, PTC Creo, Manufacturing, CATIA, Engineering, Industrial Engineering, PFMEA, Test Method Validation, IQ, OQ, PQ, Supplier Quality..., Process Validation, CAPA, NCR, Root Cause Analysis
Education
New Jersey Institute of Technology 2013 — 2015
Master's degree, Industrial Engineering, 3.66
Terumo Cardiovascular Systems April 1997 - Present
Smith & Nephew Orthopaedics April 1991 - March 1997
3M Health Care/AVI 1987 - 1991
Education
Syracuse University - Martin J. Whitman School of Management 1982 — 1986
Bachelor of Science (BS), Marketing/Marketing Management, General
PSEG Nuclear June 2013 - Present
PSEG May 2012 - August 2012
Terumo Cardiovascular Systems May 2011 - August 2011
Skills
Aspen Plus, 5S, Simulink, Polymath, Microsoft Office 2007, Matlab
Education
Rowan University 2009 — 2013
Bachelor of Science (B.S.), Chemical Engineering
Terumo Cardiovascular Systems July 2014 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, English, Windows
Education
Quincy College 2004 — 2007
Associate of Arts and Sciences (A.A.S.), Mathematics
Southwest Minnesota State University 2003 — 2004