St. Jude Medical
Industry: Medical device company
DescriptionSt. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries. Headquarters: Saint Paul, Minnesota, United States Founded: 1976, Saint Paul, Minnesota, United States CEO: Michael T. Rousseau (Jan 2016–) Subsidiaries: St. Jude Medical Belgium, MediGuide Inc, Founders: Manny Villafana, Manuel A. Villafana Parent organization: St. Jude Medical Luxembourg Holding S.a r.l.
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St. Jude Medical Employees
St. Jude Medical February 2013 - Present
Eli Lilly and Company March 2010 - January 2013
Quintiles October 2006 - December 2009
Activate Cellular November 2005 - October 2006
Jovick Construction and Design January 2004 - November 2005
St Patrick hospital and Health Sciences Center June 2003 - November 2003
Skills
Sales, Sales Operations, Pharmaceutical Sales, Pharmaceutical Industry, Customer Service, Leadership, Marketing, New Business Development, Medical Devices, Selling, Sales Management, Account Management
Education
Southern Oregon University 2001 — 2004
Bachelor of Science, Sociology
Northwest College 2000 — 2001
Associates Arts, General Studies
The University of Montana 1997 — 2000
Culinary Arts, Food Service Management
Minco Products, Inc November 2014 - Present
Clareys Safety Equipment Inc February 2013 - November 2014
Clareys Safety Equipment Inc October 2011 - February 2013
St. Jude Medical September 2009 - June 2010
Skills
Management, Inspection, Microsoft Office, NFPA, Training, Hazardous Materials, Life Safety, Emergency Management, Emergency Medical, Team Building, Testing, First Aid, Customer Service, Six Sigma, Lean Manufacturing, CI, Fixture Design, Fixtures, ECR, IFS, SolidWorks, A3 Thinking, Risk Analysis, Tooling Design, Engineering Support, New Product..., Cost Savings, Continuous Improvement, Manufacturing, Standard Work, Troubleshooting, New Product..., IFS ERP
Education
Minnesota School of Business-Brooklyn Center 2007 — 2009
Music Management
North Hennepin Community College
Associate’s Degree, Pre-Engineering
PwC August 2014 - Present
Northwestern University President's Office January 2012 - December 2013
St. Jude Medical June 2013 - September 2013
Baxter Healthcare June 2012 - September 2012
Emerson Process Management June 2011 - December 2011
Skills
Matlab, Biomedical Engineering, Microsoft Office, Validation, Labview, Data Analysis, Microsoft Excel, GMP, Microsoft Word
Education
Northwestern University 2010 — 2014
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Northwestern University 2010 — 2014
Bachelor's Degree, Biomedical Engineering
St. Jude Medical September 2013 - Present
LSU Health Sciences Center March 2003 - August 2013
CHRISTUS Health September 1992 - September 2002
Skills
Inventory Management, Budget Management, Budget Analysis, PACS, Healthcare Management, Healthcare, Healthcare IT, Hospitals, Billing, Budgeting, Excel, Microsoft Office, Clinical, Contract Negotiation, Purchasing, EMR, Meditech, Management, Epic Systems, Radiology, Patient Safety, Strategic Planning, Medical Imaging, HL7, Revenue Cycle, Cpr Certified, Interventional Radiology, Quality Improvement, DICOM, Cath Lab, Digital Imaging, HIPAA, Cardiology, Medical Terminology, Health Information..., JCAHO, Patient Education, Medical Devices, CPT, Healthcare Information..., Inpatient, Clinical Research, Surgery
Education
Northwestern State University 2009 — 2011
B.S., Radiological Sciences
Bossier Parish Community College 2006 — 2007
A.D., Computer Information Systems
Forde Design July 2011 - Present
NMT Medical, Inc. August 1999 - August 2011
C.R. Bard April 1996 - August 1999
St. Jude Medical 1992 - 1996
Skills
Medical Devices, Solidworks, FDA, R&D, Product Design, Design Control, Design for Manufacturing, Validation, Engineering, Product Development, Medical Device R&D, Patents
Education
Northeastern University
Salix Pharmaceuticals March 2015 - Present
St. Jude Medical July 2014 - March 2015
Bayer May 2007 - July 2014
CV Therapeutics 2006 - 2007
Skills
Medical Devices, Thrombectomy, Atherectomy, Capital Equipment, International Sales, Cardiology, Vascular, Cath Lab, Catheters, Interventional Radiology, Interventional..., Sales Force Development, Pharmaceutical Sales, Sales Operations, Vascular Surgery, Market Development, Peripheral Vascular, Operating Room, Surgical Device Sales, Sales Process, Proctoring, Work Independently with..., Capital Equipment Sales, Product Launch, Surgical Instruments, ENT, Cardiac Surgery, Medical Sales, Neurosurgery
Education
Northern Illinois University 1993 — 1996
BS, Business
St. Jude Medical November 2014 - Present
The Nerdery June 2014 - November 2014
St. Jude Medical April 2013 - June 2014
D'Amico and Partners June 2006 - April 2013
Skills
SAP HCM, Reporting & Analysis, Data Migration, Employee Benefits, SAP HR, Kronos WFC, Employee Relations, Applicant Tracking..., Background Checks, Data Integrity, Customer Service, Employee Training, Team Building, Training, Human Resources
Education
Northwestern College 2001 — 2005
Bachelor of Arts (B.A.), Psychology
Cordis March 2015 - Present
Baptist Health System April 2014 - April 2015
CR Bard December 2014 - March 2015
St Jude Medical January 2006 - January 2014
Brookwood Medical Center 2003 - 2006
Coffee Health Group 1997 - 2003
US Army August 1988 - January 1998
Skills
Interventional..., Medical Devices, Interventional Radiology, Cardiology, Cath Lab, Pacemakers, Operating Room, Cardiac Rhythm..., Vascular, Hospitals, Radiology, Vascular Surgery, Clinical Support, Catheters, Peripheral Vascular, Cardiac Cath, Stents, X-ray, Medical Imaging
Education
University of Alabama at Birmingham 1995 — 1997
Bachelor of Science, Radiologic Technology/Science - Radiographer
Northwest Shoals Community College-Muscle Shoals 1993 — 1995
Associate's degree, General Studies
St. Jude Medical January 2009 - Present
St. Jude Medical March 2007 - December 2008
St. Jude Medical September 2003 - March 2007
Skills
Medical Devices, Pre-clinical Studies, GLPs, GCPs, Biomedical Engineering, Design of Experiments, Animal Models, Product Development, FDA, ISO 13485, Electrophysiology, V&V, PMA, Design Control
Education
Northeastern University 2009 — 2011
Master's, Regulatory Affairs
UC Irvine Extension 2007 — 2008
Certificate in Clinical Trials: Medical Device and Drug Development, Clinical Research
Villanova University 2006 — 2006
Essentials of Project Management Certificate
UC Irvine 1999 — 2003
BS, Biological Sciences
M.Parisi Consulting May 2010 - Present
Allergan March 2014 - January 2015
Ventana Medical Systems May 2012 - January 2014
St. Jude Medical May 2008 - May 2010
Alcon Labs October 2007 - May 2008
Boston Scientific March 1999 - May 2007
Boston Scientific January 1998 - September 1999
Boston Scientific December 1996 - January 1998
Moltech Corporation September 1995 - September 1996
Various Research Institutions 1992 - 1995
Skills
Cross-functional Team..., Medical Devices, Quality System, R&D, Validation, FDA, V&V, Design Control, ISO 13485, CAPA, Product Development, Quality Control, Manufacturing, GMP, Process Improvement, Process Simulation, Product Launch, Testing, 21 CFR Part 11, Program Management, Project Management, Quality Assurance, Design of Experiments, Change Control, Commercialization, Training, Biomedical Engineering, Engineering Management, Six Sigma, DMAIC, Quality Management, Process Engineering, SPC, Supplier Quality, Management, Sop, Business Development, Continuous Improvement, Engineering, Strategy, Business Process..., Quality Auditing, Lean Manufacturing, Business Process, Computer System..., Regulatory Affairs, FMEA, Root Cause Analysis, ISO, Minitab
Education
University of Arizona 1993 — 1995
Master's Degree, Nuclear and Energy Engineering
University of Wisconsin-River Falls 1991 — 1993
Bachelor's Degree, Physics, Chemistry with Biochemistry Emphasis
North Hennepin Community College 1989 — 1991
Associate's Degree, General Education
Graduate Business Courses
Business, Organizational Development
St. Jude Medical
Skills
Medical Devices, Electrophysiology, Healthcare, Cardiac..., Disposables, Cardiac Rhythm..., Cardiology, Catheters, Capital Equipment, ISO 13485, Medical Imaging, FDA, Interventional..., Market Development, Commercialization
Education
Northeastern University 1995 — 1998
Bachelor's degree, Cardiopulmonary Science
Boston Scientific April 2015 - Present
Sacred Heart Medical Center October 2013 - April 2015
St. Jude Medical 2012 - October 2013
St. Jude Medical 2008 - 2012
PeaceHealth 2003 - 2007
Skills
Medical Devices, Clinical Research, Team Building, Cardiac Rhythm..., Market Development, Healthcare Industry, Radiology
Education
Gonzaga University
Masters of Organizational Leadership Candidate, Business Administration, Management and Operations
Northwest Christian College
Bachelor's degree, Business Administration and Management, General
Globus Medical June 2014 - Present
St. Jude Medical June 2012 - May 2014
Fikst Product Development July 2011 - January 2012
Nuvera Fuel Cells July 2010 - January 2011
Raytheon May 2009 - January 2010
Skills
Solidworks, Testing, Manufacturing, Machining, Six Sigma, Product Development, Rapid Prototyping, Troubleshooting, Pro Engineer, ANSYS, Matlab, Finite Element Analysis, Labview, Mechanical Engineering, Design for Manufacturing, Engineering, PTC Creo, SolidWorks
Education
Northeastern University 2012 — 2015
Master's Degree, Mechanical Engineering
Gordon Engineering Leadership Program at Northeastern University 2012 — 2013
Gordon Fellow, holding graduate certificate of Engineering Leadership
Northeastern University 2007 — 2012
Bachelor of Science (B.S.), Mechanical Engineering
St. Jude Medical February 2015 - Present
USIS November 2013 - August 2014
CGI May 2009 - September 2013
Arizona Army National Guard February 2004 - February 2010
Skills
Analytics, Intelligence Analysis, Team Leadership, Leadership, Military Experience, Customer Service, Microsoft Office, DoD, Security Clearance
Education
PrepMD 2014 — 2015
Certificate, Cardiac Rhythm Management
Northern Arizona University 2008 — 2009
Bachelor of Science (B.S.), Criminal Justice/Law Enforcement Administration
St. Jude Medical February 2009 - Present
ViaLogy LLC March 2007 - January 2009
UCLA Medical Center March 2003 - March 2007
ETomei, Inc September 1999 - September 2002
Skills
Java Enterprise Edition, Web Services, Spring, XML, Tomcat, Eclipse, SQL, Java, JBoss Application Server, JSP, JDBC, Hibernate, Struts, SOAP, Unix, Software Development, Design Patterns, Agile Methodologies, Software Engineering, JMS, Websphere, Apache, Oracle, AJAX, Servlets, JavaScript, Shell Scripting, REST, WebSphere Application..., Databases, XSLT, MySQL, Weblogic, WebSphere
Education
Yale University - Yale School of Management 2015 — 2017
Master of Business Administration (M.B.A.), Health/Health Care Administration/Management
North Maharashtra University 1995 — 1999
Bachelor of Engineering (B.E.), Computer Engineering, First Class with Distinction
Andrews Business Solutions, LLC 2008 - Present
St Jude Medical 2015 - Present
Avedro, Inc. 2014 - 2015
ValuTrack Corporation 2012 - 2014
Medical Development Group (MDG) 2011 - 2014
Harvard Apparatus 2012 - 2013
Hologic 2009 - 2012
NxStage Medical 2009 - 2010
Harvard Apparatus 2008 - 2009
Intertech Engineering Associates 1994 - 2008
Skills
Medical Devices, Quality Systems, FDA, Embedded Systems, Diagnostics, Testing, Engineering, Validation, Product Development, ISO 13485, QSR, R&D, Design Control, FMEA, Quality Assurance, Requirements Analysis, ISO 62304, ISO 14971, 21 CFR Part 11, Quality System, Hardware Diagnostics, ISO
Education
Northeastern University
Engineer's Degree, Bachelors of Science in Electrical Engineering
ARKRAY USA, Inc. 2013 - Present
DiaSorin Inc 2012 - 2013
Heraeus Medical Components 2011 - 2012
Coloplast 2006 - 2010
St. Jude Medical 2000 - 2006
Minntech Corporation 1996 - 2000
Medtox Laboratories 1994 - 1996
Skills
Medical Devices, Product Development, Capital Equipment, Strategic Planning, Cross-functional Team..., Product Launches, FDA, Hospitals, Process Improvement, P&L Management, ISO 13485, Product Launch, R&D, Healthcare, Customer Relations, Surgery, Compliance, Manufacturing, Cardiac, Consultative Selling, Marketing Management, Sales Support, Team Leadership, Product Marketing, Marketing Strategy, Segmentation, Cardiology, Product Management, Contract Negotiation, Problem Solving, Negotiation, Strategy Development, Budgeting, P&L, Market Development, Market Research, Competitive Analysis, Market Analysis, Sales Operations, Team Building, Contract Negotiations, Forecasting, Pricing, Mentoring, Change Management, Key Account Management, Global Marketing, Continuous Improvement, Pricing Strategy, Strategy
Education
University of Minnesota - Carlson School of Management 1998 — 1998
Fundamentals of Marketing
University of Minnesota-Twin Cities 1990 — 1993
Bachelor of Science, Microbiology
Northwestern College 1986 — 1988
Bachelor of Science (B.S.), Music Performance, General
St Jude Medical March 2013 - Present
St. Jude Medical December 2006 - March 2013
Summit on 7 Condominiums June 2007 - January 2013
Express Scripts February 2005 - December 2006
Capella University November 2003 - February 2005
Thrivent Financial November 2002 - October 2003
Metris Companies June 1998 - December 2002
Minneapolis Hilton and Towers May 1996 - June 1998
Skills
Six Sigma, Teamwork, Outlook, Leadership, Microsoft Excel, PowerPoint, Microsoft Word, Process Improvement, Customer Satisfaction, Community Outreach, Analysis, Recruiting, Quality Assurance, Management, Team Building, Training, Human Resources, Microsoft Office, Operations Management, Team Leadership, Call Centers, Event Management, Inventory Management, Strategic Planning, SharePoint, Budgets, Time Management, Leadership Development
Education
Regis University 2014 — 2015
Bachelor's degree, Communications
North Hennepin Community College 1994 — 1997
Associate of Arts and Sciences (A.A.S.)
Hopkins High School 1991 — 1994
General, General
Abiomed March 2012 - Present
iRobot December 2009 - March 2012
Teleflex Medical May 2007 - June 2009
Boston Scientific December 2005 - February 2007
Cisco January 2001 - November 2005
Hewlett-Packard June 1997 - January 2001
GSI Medical Products Group June 1996 - June 1997
St. Jude Medical 1990 - 1996
Skills
Engineering Management, Engineering, Manufacturing, Design for Manufacturing, Robotics, PCB design, Design of Experiments, Electronics, R&D, FMEA, Embedded Systems, Systems Engineering, Electrical Engineering, Labview, Product Development, Cross-functional Team..., Medical Devices, Testing, Six Sigma, Hardware, ISO 13485, Manufacturing..., Lean Manufacturing, Root Cause Analysis
Education
Northeastern University 1984 — 1989
MSEE, Electrical Engineering
Northeastern University
Master's degree in Electrical Engineering
St. Jude Medical April 2015 - Present
St. Jude Medical July 2012 - April 2015
St. Jude Medical January 2005 - July 2012
Endocardial Solutions February 2003 - January 2005
TRIAD Conferences 2002 - 2002
Lawson Software 1986 - 2002
Skills
Product Launch, Medical Devices, Trade Shows, Marketing Strategy, Project Management, Lead Generation, Marketing Communications, Product Management, Budgets, Management
Education
North Hennepin Community College 1978 — 1980
Associate of Arts (A.A.), Business
Crescendo EMC July 2014 - Present
Covidien July 2010 - July 2014
St. Jude Medical February 2006 - December 2009
St. Jude Medical February 2006 - December 2009
American Heart Association November 2002 - February 2006
American Heart Association 2002 - 2006
Event Energy December 2001 - November 2002
Shimadzu Medical Systems January 1991 - November 2002
Shimadzu Medical Systems January 1990 - December 2001
Skills
Strategic Planning, Contract Negotiation, Team Management, Supplier Evaluation, Medical Education, Process Simulation, Trade Shows, Medical Devices, Product Launch, Marketing Strategy, Marketing Communications, Product Marketing, Budgets, Event Management, Account Management, Integrated Marketing, Marketing, Business Development, Sponsorship, Strategy, Management, Advertising, Program Management, Sales, Leadership, Creative Direction, Relationship Marketing, Marketing Management, Selling, Cross-functional Team..., Global Marketing, Lead Generation, Market Planning, Competitive Analysis
Education
Northwestern University
Northwestern University
Business/Corporate Communications
Sorin Group 2007 - 2009
St. Jude Medical 1997 - 2007
Intermedics 1981 - 1997
Skills
Market Development, Disposables, Capital Equipment, Management, Medical Devices, Operating Room, Recruiting, Cardiology, Interventional...
Education
Northeastern University
BA, Liberal Arts - Poly Sci
St. Jude Medical March 2014 - Present
St. Jude Medical August 2011 - December 2013
PaR Systems July 2010 - August 2011
Boston Scientific 2008 - 2010
MTS Systems Corporation 2006 - 2008
Pentair Thermal Management January 1999 - June 2006
McLean Cooling Technologies January 1996 - January 1999
Skills
Medical Devices, ISO, Manufacturing, Auditing, Occupational Health, ISO 13485, CAPA, ISO 14971, FDA, Root Cause Analysis, Design Control, Continuous Improvement, Quality Auditing, Six Sigma, DMAIC, FMEA, Lean Manufacturing, V&V, Validation
Education
Northwestern College
Bachelor of Science, Communcation Studies
Edwards Lifesciences March 2014 - Present
Edwards Lifesciences April 2010 - February 2014
St. Jude Medical April 2005 - March 2010
ePartners March 2001 - March 2005
Cole Systems Associates, Inc. 1998 - 2001
McMaster-Carr September 1996 - February 1998
Education
Northwestern University 1992 — 1996
Remmele Medical July 2011 - Present
St. Jude Medical June 2007 - September 2008
Aveda October 2000 - June 2007
Aveda October 1998 - October 2000
Skills
MRP, Procurement, Master Scheduling, Purchasing, Inventory Management, Materials, Kanban, SAP, Medical Devices, Capacity Planning, Inventory Control, Materials Management, Production Planning, Supply Chain, GMP
Education
Northwestern College 1994 — 1998
BA, Biology, Biblical Studies
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
Smiths Medical September 2014 - Present
Strategic PLM September 2013 - Present
Zero Wait-State November 2013 - September 2014
WuXi AppTec March 2013 - August 2013
St. Jude Medical June 2012 - March 2013
St. Jude Medical October 2011 - July 2012
St Jude Medical January 2010 - October 2011
AGA Medical November 2007 - January 2010
STERIS, Isomedix March 2006 - November 2007
Cardiac Science October 2003 - March 2006
Skills
Quality System, Medical Devices, FDA, ISO 13485, Lean Manufacturing, Design Control, Process Improvement, Manufacturing, CAPA, Change Management, Software Documentation, Quality Auditing, Validation, ISO, Product Lifecycle..., Six Sigma, Change Control, FMEA, Cross-functional Team..., Continuous Improvement, Quality Assurance, SPC, Organizational..., ISO 14971, Root Cause Analysis, Sop, 21 CFR Part 11, DMAIC, Quality Management, GMP, Supplier Quality, Leadership, Minitab, Strategic Planning, Quality Control, Product Launch, Kaizen, Process Engineering, Manufacturing..., Product Development, 5S, Regulatory Affairs, Complaint Management, Manufacturing Operations, Process Simulation, Oracle Agile PLM
Education
University of St. Thomas - Opus College of Business 2010 — 2013
MBA, Executive MBA
University of St. Thomas 2006 — 2006
Mini Masters, Medical Technology Management
Northwestern College 2003 — 2006
BS, Business Management
Minneapolis Drafting School 1998 — 2000
Mechanical / Electronic Drafting
Peach Medical August 2015 - Present
St. Jude Medical July 2014 - July 2015
Cook Medical February 2012 - June 2014
ZOLL Medical Corporation April 2008 - February 2012
ZOLL Medical February 2006 - April 2008
ZOLL Medical March 2004 - January 2006
Skills
Medical Devices, Hospitals, Product Launch, Capital Equipment, Operating Room, Surgeons, Cardiology, Market Development, Disposables, Interventional..., Product Development, Vascular, Healthcare, Surgery, Sales Force Development, Cath Lab, Sales Effectiveness, Clinical Research
Education
Suffolk University - Sawyer Business School 2005 — 2008
Masters, Health Administration
Northeastern University 1998 — 2003
BA, Business
Abbott Vascular January 2014 - Present
St. Jude Medical July 2012 - December 2013
Amgen October 2011 - July 2012
Baxter December 2009 - February 2011
Franklin Square Hospital Center June 2008 - May 2009
Care For All Charity, Saint George's University School of Medicine August 2005 - December 2005
Saint George's University School of Medicine September 2004 - September 2004
Cedars-Sinai Medical Center June 2004 - August 2004
University of Pennsylvania School of Medicine October 2001 - December 2003
University of Pennsylvania School of Medicine September 1998 - October 2001
Skills
Oncology, Cell Culture, Statistics, Molecular Biology, Clinical Research, Clinical Trials, Microsoft Office, C++, Immunoassays, Cell Biology, Matlab, Minitab, PubMed, Medical Devices, Cardiovascular Disease, FDA, ICH-GCP, Clinical, Cancer Immunotherapy
Education
Saint George's University 2004 — 2008
MD
University of Pennsylvania 1997 — 1998
Masters of Science in Engineering, Bioengineering
Northwestern University 1992 — 1996
Bachelors of Science, Biomedical Engineering
Whitney High School
Stryker August 2015 - Present
Society of Women Engineers - Golden Gate Section June 2013 - Present
Stryker (fka CoAlign Innovations) January 2013 - August 2015
Society of Women Engineers - Minnesota October 2012 - June 2013
Society of Women Engineers July 2012 - June 2013
St. Jude Medical April 2012 - December 2012
Society of Women Engineers - Minnesota July 2012 - September 2012
University of Minnesota October 2010 - April 2012
CIMA Labs June 2011 - September 2011
University of Minnesota December 2010 - May 2011
Skills
Biomedical Engineering, ELISA, R&D, Immunoassays, Medical Devices, C++, Visio, PCR, Laboratory, Matlab, Customer Service, GMP, SolidWorks, Microsoft Office, Cell Culture, LabVIEW, Chinese, Mathlab, CAPA, Manufacturing, Quality System, Quality System..., Change Control, Cross-functional Team..., FDA QSR, ISO 13485
Education
Santa Clara University 2015 — 2017
Master of Science (M.S.), Engineering Management and Leadership
University of Minnesota-Twin Cities 2008 — 2011
Bachelor of Biomedical Engineering, Biomedical Enginering
North Seattle College 2006 — 2008
AA, Engineering and Science
St. Jude Medical January 2009 - Present
St. Jude Medical May 2007 - July 2008
Boston Scientific 2004 - 2007
Endocardial Solutions 2001 - 2004
Brigham and Women's Hospital 1999 - 2001
Skills
Electrophysiology, Atrial Fibrillation, Cath Lab, Interventional..., Medical Devices, Capital Equipment, Cardiology, Pacemakers, Cardiac Rhythm..., Catheters, Disposables, Capital Equipment Sales, Medical Sales, Ultrasound, Hospitals, Cardiac..., Healthcare
Education
Northeastern University 1995 — 1999
BS, Cardiopulmonary Science
Analog Devices September 2014 - Present
St. Jude Medical February 2012 - August 2014
Sensata Technologies 2010 - 2012
Intelligent Innovation September 2002 - September 2009
Analog Devices February 1999 - August 2001
Teradyne September 1997 - September 1999
Raytheon April 1988 - March 1995
Skills
Product Development, FDA, Software Documentation, Microsoft Office, Technical Writing, Cross-functional Team..., Engineering, FMEA, Leadership, Process Improvement, Project Management
Education
Northeastern University 1989 — 1995
Master of Business Administration (M.B.A.)
University of Massachusetts, Amherst 1983 — 1988
Bachelor's Degree, Industrial Engineering/Operations Research
St. Jude Medical 2001 - Present
St. Jude Medical November 1985 - August 1994
Skills
Surgery, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Customer Service, Medical Devices, IT, Customer Service,..., Healthcare, Cardiology, Capital Equipment, Hospitals, Orthopedic, Market Development, Operating Room
Education
Northwestern College 1984 — 1988
Bachelor's degree, Elementary Education and Teaching
Mpls Live Magazine June 2015 - Present
St. Jude Medical May 2015 - Present
MKTG INC March 2015 - Present
Wellness Company January 2015 - Present
St. Jude Medical August 2014 - May 2015
Oxygen Plus, Inc. 2013 - March 2014
Life Time Fitness June 2013 - November 2013
Kiehl's Since 1851 October 2012 - June 2013
Freedom Mortgage February 2012 - October 2012
Clinique November 2011 - October 2012
Skills
Long-term Customer..., Complaint Management, Yield Management, Customer Engagement, Consulting, Customer Retention, Sales Presentations, Wellness, Training, Business Development, Time Management, Customer Experience, Salesforce.com, Leadership, Spa, Event Management, Customer Service, Inventory Management, Social Media, Customer Satisfaction, Retail, Nutrition, Fitness, CRM, Entrepreneurship, Cold Calling, Merchandising, Forecasting, Skin Care, Product Marketing, Sales, Management, Marketing, Team Building, Event Planning, Coaching, Social Networking, Public Speaking, Marketing Strategy, Social Media Marketing
Education
Crown College
Bachelor of Business Administration (B.B.A.), Marketing/Marketing Management, General
Coulee Christian School
Northeast Wisconsin Technical College
Psychology
Medtronic August 2015 - Present
Medtronic February 2013 - July 2015
St. Jude Medical May 2011 - February 2013
St. Jude Medical March 2009 - May 2011
St. Jude Medical October 2007 - March 2009
Skills
Medical Devices, FDA, Biomedical Engineering, Cardiology, Cross-functional Team..., R&D, Clinical Research, Market Development, Product Launch, ISO 13485
Education
Northwestern University 2004 — 2007
PhD, Electrical and Computer Engineering
Northwestern University 2002 — 2004
MS, Computer Engineering
St. Jude Medical October 2013 - Present
Baptist Memorial Hospital September 2005 - January 2015
Skills
Microsoft Office, Clinical Research, Microsoft Excel, Microsoft Word, Customer Service, Hospitals, PowerPoint, Surgery, Medicine, Healthcare Management, Treatment
Education
Northwest Mississippi Community College 2002 — 2005
Associate's of Applied Science, Cardiovascular Technology/Technologist
St. Jude Medical 2013 - Present
St. Jude Medical 2008 - 2013
Medtronic 2006 - 2008
US Army 1999 - 2007
Education
Northwestern University - Kellogg School of Management
Master of Business Administration (MBA)
Penn State University
Master of Engineering Management (MEM)
United States Military Academy at West Point
Bachelor of Science (B.S.)
American Medical Systems May 2015 - Present
Banyan Community January 2015 - Present
superDimension/Covidien/Medtronic January 2014 - May 2015
superDimension / Covidian May 2012 - January 2014
superDimension February 2009 - May 2012
St. Jude Medical, CVD November 2007 - February 2009
St. Jude Medical July 2004 - November 2007
Skills
Medical Devices, ISO 13485, Design Control, FDA, CAPA, V&V, Biomedical Engineering, Design for Manufacturing, Catheters, Quality System, Design of Experiments, R&D, ISO 14971, Minitab, Six Sigma, Cross-functional Team..., Quality Control, Value Stream Mapping, DMAIC, Failure Analysis, Root Cause Analysis, Validation, Lean Manufacturing, Machining, Product Design, Manufacturing..., Engineering, SPC, Product Launch, Product Development, Process Simulation, GMP, Quality Assurance, Manufacturing, Continuous Improvement, Engineering Management, Commercialization, Quality Management, FMEA, Project Management, ISO, Injection Molding, Supplier Quality, GD&T, Capital Equipment, Quality Auditing, Manufacturing Operations, Sterilization
Education
University of Saint Thomas - School of Business 2006 — 2011
MBA, MBA
North Dakota State University 1999 — 2004
BS, Mechanical Engineering
Hopkins High School 1997 — 1999
High School Diploma
St. Jude Medical June 2011 - Present
St. Jude Medical May 2010 - June 2011
Douglas Machine January 2011 - May 2011
Beckman Coulter May 2009 - September 2009
Skills
R&D, Product Design, Product Development, Concept Generation, Product Prototyping, Mechanical Engineering, Biomedical Engineering, Medical Devices, Machine Design, Fixture Design, Test Method Development, V&V, Solidworks, Design for Manufacturing, Design for Injection..., Machining, FMEA, Design Control, Matlab, Minitab, Design of Experiments, Test Methodologies, Injection Molding, SolidWorks
Education
University of Minnesota-Twin Cities 2007 — 2011
Bachelor of Engineering (B.E.), Mechanical Engineering
North Hennepin Community College 2004 — 2006
Associate of Arts (A.A.), Pre-Engineering
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
Medigram, Inc. 2014 - Present
AliveCor 2012 - 2013
St. Jude Medical 2003 - 2011
Arthur Andersen 2001 - 2002
Emerging.com 2000 - 2001
Deloitte Consulting 1999 - 2000
Skills
Medical Devices, Cardiology, Strategy, Product Management, Product Launch, Healthcare, Product Marketing, Start-ups, Sales, Pacemakers, Cardiac Surgery, Hospitals, Cross-functional Team..., Clinical Research, Market Development, Software Development, SaaS, Healthcare Technology, Go-to-market Strategy, Healthcare Information..., Marketing, Sales Operations, Capital Equipment, Vascular, Disposables, Interventional..., Surgeons, CRM, Operating Room, Business Development, Electrophysiology, New Business Development, Enterprise Software, Competitive Analysis, Selling, Interventional Radiology, Commercialization, Biomedical Engineering, Global Marketing, Sales Marketing, Technology Consulting, Clinical, Customer Relationship..., Product Development, Surgical Instruments, Cath Lab, Leadership, Healthcare Industry, Salesforce.com
Education
General Assembly 2014 — 2014
Product Management
Northwestern University
Bachelor of Arts, Major in Economics; Minor in Asian Studies
Marmion Military Academy
High School
Medtronic April 2015 - Present
St. Jude Medical February 2011 - April 2015
St. Jude Medical November 2008 - February 2011
Skills
Materials, Analytical Chemistry, Biomedical Engineering, Six Sigma, HPLC, Medical Devices, GMP, FDA, Design Control, Polymers, GLP, R&D, Materials Science, Corrosion, Characterization, CAPA, Biotechnology, Biomaterials, Validation, Quality System, Design of Experiments
Education
University of Minnesota-Twin Cities 2012 — 2016
Master's degree, Biomedical Engineering
Northwestern University 2004 — 2008
B.S, Chemical Engineering
St. Jude Medical August 2011 - Present
Vital Images January 2005 - July 2010
Radionics April 2001 - November 2003
Northeastern University November 1999 - April 2001
Harvard Pilgrim Health Care May 1989 - November 1999
Skills
Technical Writing, Localization, Software Documentation, FDA, FrameMaker, Medical Devices, Manuals, Technical Documentation
Education
Northeastern University 1986 — 1988
M.A. English, Technical Writing
University of Wisconsin-Platteville 1984 — 1986
B.S. English, Writing, American Lit.
St. Jude Medical August 2014 - Present
Tapemark January 2003 - May 2014
Tapemark 1999 - 2003
Opportunity Partners 1994 - February 1999
Opportunity Partners 1991 - 1993
Skills
ISO, Kanban, Supervising, Microsoft Word, PowerPoint, External Audit, Lean Manufacturing, Kaizen, Microsoft Excel, JIT, Internal Audit, CQA, FDA GMP, Regulatory Documentation, Project Management, Six Sigma, Quality Auditing
Education
Rasmussen College
Bachelor of Science (B.S.), Organizational Leadership
North Hennepin Community College 1989 — 1992
Associates, Business
Park Center Sr. High 1983 — 1986
St. Jude Medical April 2010 - November 2012
Dreager Medical Systems inc. March 2007 - August 2008
Education
Northern Essex Community College 2000 — 2002
Certificate of Science, Engineering
St. Jude Medical May 2009 - Present
Tufts Medical Center July 2005 - April 2009
Skills
Cardiac, Electrophysiology, Clinical, Heart Failure, Medical Devices, Cardiology, Pacemakers, Healthcare, Catheters
Education
Northeastern University 1994 — 1999
BS, Cardiopulmonary Science
Genzyme, a Sanofi company March 2015 - Present
St. Jude Medical September 2014 - January 2015
Market Access Management, LLC September 2013 - August 2014
Archimedes Pharma US, Inc. 2011 - August 2013
Genentech/Roche 2002 - 2011
Roche Pharmaceuticals 1997 - 2002
Skills
Pharmaceutical Industry, Pharmacy, Sales, Strategy, Healthcare, Leadership, Sales Effectiveness, Hospitals, Hospital Sales, Managed Care, Cross-functional Team..., Sales Management, Diabetes, Sales Operations, Account Management, Oncology, Biotechnology, Management, Product Launch, Contract Negotiation, Managed Markets, Start-ups, Strategic Planning, Endocrinology, Business Development, Market Access
Education
Northern Illinois University
Bachelor of Science (BS), Marketing
Northern Illinois University
Master of Business Administration (Executive MBA)
St. Jude Medical April 2014 - Present
Johnson & Johnson November 2012 - April 2014
Johnson & Johnson October 2011 - November 2012
Johnson & Johnson October 2010 - December 2011
USF Health Byrd Alzheimer's Institute November 2009 - September 2010
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Research, Microsoft Word, Data Analysis, Medical Devices, Time Management, Access, Leadership, Social Media, Clinical Research, Biotechnology, Clinical Trials, Pharmaceutical Industry, Analysis
Education
Northeastern University 2011 — 2012
Master's of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of South Florida 2005 — 2010
B.S., Biomedical Sciences, Biomedical Physics, Public Health
University of Cambridge 2007 — 2007
Summer Term 2007, Literature, Art History
Medtronic January 2014 - Present
ThreeWire March 2011 - January 2014
Respicardia, Inc. March 2009 - March 2011
Medtronic CRDM March 2005 - March 2009
Myocor June 2000 - March 2005
Boston Scientific/Target Therapeutics June 1998 - June 2000
St. Jude Medical June 1995 - June 1998
Skills
Medical Devices, Clinical Trials, Clinical Research, FDA, Regulatory Affairs, Cardiology, Healthcare, Product Launch, Pharmaceutical Industry, Clinical Development, R&D, Program Management, Cross-functional Team...
Education
Northwestern University 1990 — 1994
BS, Biomedical Engineering
University of Minnesota-Twin Cities 1995 — 2000
MS, Biomedical Engineering
St. Jude Medical January 2009 - May 2014
Medtronic Diabetes May 2008 - November 2008
HSBC Software Development India Ltd August 2005 - December 2006
Skills
Medical Devices, Testing, Biomedical Engineering, C, Labview, Software Development, Quality System, C++, Matlab, Design Control, ISO 13485, Certified Green Belt, Agile Methodolgy, PeopleSoft, PMP, Project Management, Scrum, FDA GMP, Business Analysis, Product Development, ClearQuest, ClearCase, Software Quality..., FDA, Cross-functional Team..., R&D
Education
University of Southern California 2007 — 2009
Masters
Cummins College of Engineering 2001 — 2005
B.E.
North Maharashtra University 1986 — 1999
High School
Cogentix Medical, Inc. April 2015 - Present
Uroplasty, Inc. June 2014 - April 2015
Uroplasty, Inc. April 2014 - June 2014
St. Jude Medical March 2013 - April 2014
American Medical Systems January 2013 - March 2013
American Medical Systems April 2010 - December 2012
American Medical Systems February 2009 - April 2010
American Medical Systems November 2006 - February 2009
St Jude Medical 2005 - 2006
Boston Scientific 2001 - 2005
Skills
Medical Devices, Regulatory Affairs, Clinical Research, FDA, Clinical Trials, Biomedical Engineering, Design Control, Cross-functional Team..., PMA, Urology, Healthcare, Clinical Study Design, Clinical Development, Cardiology, Biotechnology, ISO 13485, Surgery, CTMS, Orthopedic, Operating Room
Education
Northwestern University 1995 — 1999
BS, Biomedical Engineering
St. Jude Medical March 2015 - Present
Spectranetics June 2014 - February 2015
Spectranetics January 2012 - June 2014
Spectranetics January 2010 - January 2012
Spectranetics November 2006 - December 2010
Transoma Medical March 2005 - November 2006
Boston Scientific (formerly Guidant) November 2002 - March 2005
Gore March 2001 - November 2002
Skills
Medical Devices, Market Development, Capital Equipment, Product Launch, Commercialization, Cardiology, Operating Room, Product Development, Cross-functional Team..., Disposables, Surgeons, FDA, Business Development, Management, Sales, ISO 13485, Surgical Instruments, Vascular
Education
Fargo South High School 1980 — 1994
North Dakota State University 1984 — 1989
Industrial Engineering
St. Jude Medical November 2013 - Present
St. Jude Medical June 2011 - Present
St. Jude Medical July 2008 - September 2011
OptumHealth February 2008 - July 2008
Boston Scientific April 1991 - December 2007
Boston Scientific (formerly Guidant) 1991 - 2007
Skills
Medical Devices, 21 CFR Part 11, Software Documentation, ISO 13485
Education
Northwestern College 1988 — 1991
Entellus Medical August 2015 - Present
Interrad Medical January 2011 - Present
Interrad Medical November 2006 - January 2011
Velocimed July 2004 - November 2006
St. Jude Medical 2005 - 2006
Velocimed June 2002 - July 2004
Skills
Medical Devices, ISO 13485, FDA, Quality System, Design of Experiments, Design Control, Solidworks, Healthcare, Software Documentation, ISO 14971, R&D, V&V, CAPA, Validation
Education
North Hennepin Community College 1999 — 2006
A.S., Business Management
St. Jude Medical August 2010 - Present
Softscope Medical May 2007 - August 2010
Boston Scientific 1995 - 2007
Education
University of St. Thomas - Opus College of Business
MBA
North Dakota State University 1981 — 1985
Mechanical Engineering
Entellus Medical June 2008 - Present
Entellus Medical October 2007 - May 2008
Entellus Medical February 2007 - October 2007
St. Jude Medical 2004 - 2006
Velocimed 2002 - 2004
TERAMed, Inc. 1998 - 2002
Mentor Corporation 1992 - 1997
Skills
Medical Devices, Design Control, ISO 13485, Biomedical Engineering, V&V, FDA, Product Launch, Market Development, Commercialization, Product Development, CAPA, Quality System, Design of Experiments, Validation, Manufacturing, Product Management, Design for Manufacturing, FMEA, Cross-functional Team..., GMP
Education
North Dakota State University 1986 — 1991
Mechanical Engineering
St. Jude Medical February 2009 - Present
University of Minnesota May 2006 - Present
Entegris February 2007 - June 2008
Boston Scientific 1995 - 2007
Boston Scientific May 2004 - April 2006
North Hennepin Tech. 1993 - 1996
Skills
Medical Devices, ISO 13485, Manufacturing..., Process Simulation, Design of Experiments, Design Control, Injection Molding, Six Sigma, Engineering, Cross-functional Team..., Manufacturing, Design for Manufacturing, FDA, Validation, V&V, Continuous Improvement, CAPA, Quality System, Semiconductors, Product Development, R&D
Education
University of St. Thomas 2013 — 2017
Master of Business Administration (MBA), Management
University of Saint Thomas 2007 — 2012
MA, Human Resources & Organizational Development
University of St. Thomas 2003 — 2005
MS, Manufacturing Systems
University of St. Thomas 2000 — 2003
BA, Theology & Philosophy
North Hennepin Community College 1995 — 2000
AAS, Plastics Technology
St. Jude Medical March 2014 - Present
St. Jude Medical August 2012 - Present
Boston Scientific January 2009 - August 2012
Boston Scientific July 2007 - January 2009
Boston Scientific January 2001 - July 2007
Boston Scientific July 1998 - January 2001
Hutchinson Technology Incorporated November 1993 - July 1998
Skills
Design Control, Design of Experiments, ISO 13485, Medical Devices, Minitab, Design for Manufacturing, V&V, FMEA, CAPA, FDA, Quality System, Catheters, SPC, Root Cause Analysis, Lean Manufacturing, DMAIC, Six Sigma, Manufacturing..., Solidworks, Manufacturing, ISO 14971, Engineering, Continuous Improvement, Electronics, Process Engineering, R&D, Quality Control, Validation
Education
University of Minnesota-Twin Cities 2005 — 2009
Bachelors, Mechanical Engineering
North Hennepin Community College 1999 — 2005
AS, Pre-Engineering
Northcentral Technical College 1990 — 1993
(2) AS Degs, Laser Technology and Electronics
St. Jude Medical February 2010 - Present
Cartika Medical November 2006 - February 2010
Enpath Medical 1999 - 2006
Flexmedics 1995 - 1999
Education
Northwestern College 1991 — 1995
St. Jude Medical March 2014 - Present
St. Jude Medical March 2008 - Present
Boston Scientific April 1999 - December 2007
Angeion Corporation January 1996 - April 1999
Jeane Thorne Inc. May 1994 - January 1996
Skills
Administrative..., Medical Devices, Visio, Outlook, Concur, Microsoft Excel, PowerPoint, Process Improvement, Calendaring, Microsoft Word, Microsoft Office, SharePoint, Software Documentation, Office Management, Budgets, Time Management, Sales, Access, PeopleSoft
Education
North Hennepin Community College
St. Jude Medical November 2010 - Present
AGA Medical November 2010 - January 2012
Skills
Minitab, FDA, Injection Molding, Engineering, Design of Experiments, ISO 13485, CAPA, Medical Devices, Product Development, Quality System, V&V, FMEA, Biomedical Engineering, Validation, R&D, Design Control, Design for Manufacturing
Education
University of Minnesota-Twin Cities 2007 — 2009
MS, Management of Technology
Northwestern University 1992 — 1996
BS, Biomedical Engineering
St. Jude Medical March 2015 - Present
St. Jude Medical March 2014 - February 2015
St. Jude Medical May 2013 - March 2014
St. Jude Medical May 2012 - April 2013
St. Jude Medical March 2010 - April 2012
St. Jude Medical November 2008 - March 2010
Boston Scientific December 2005 - November 2008
Boston Scientific December 2001 - December 2005
Boston Scientific April 2001 - December 2001
Minntech Corporation 2000 - 2001
Skills
ISO 13485, Engineering, Design of Experiments, Catheters, Design Control, Manufacturing, Quality System, Product Development, Engineering Management, 5S, Medical Devices, CAPA, FMEA, V&V, Lean Manufacturing, Design for Manufacturing, Continuous Improvement, ISO, FDA, Cross-functional Team..., Injection Molding, Root Cause Analysis, Six Sigma, Manufacturing..., Validation, Minitab
Education
University of Minnesota-Crookston 2007 — 2012
Bachelors, Manufacturing Management
North Hennepin Community College 2004 — 2007
Hennepin Technical College 1992 — 1994
2 year, Environmental-Chemical Technology
Stanford University August 2015 - Present
Coapt January 2015 - June 2015
Rehabilitation Institute of Chicago April 2014 - May 2015
American Medical Systems June 2009 - July 2013
University of Minnesota September 2008 - May 2009
St. Jude Medical June 2008 - May 2009
Skills
Medical Devices, Biomedical Engineering, Engineering, R&D, Product Development, Machining, Design Control, Design Verification..., Welding, Design of Experiments, Testing, ISO 13485, Matlab, FDA, SolidWorks, Prototyping
Education
Northwestern University 2013 — 2015
Master of Science (MS), Biomedical Engineering
University of Minnesota-Twin Cities 2005 — 2009
Bachelor's degree, Biomedical Engineering
St. Jude Medical Clinical EngineerBoston ScientificDecember 2001 - August 2006
Education
Northeastern University 2005 — 2008
BS, Cardiopulmonary Science
St. Jude Medical January 2010 - Present
St. Jude Medical, Inc. 1994 - 2009
Education
Northwestern College 1985 — 1990
Elementary Education
St. Jude Medical January 2003 - Present
Acuson-Siemens January 1990 - January 2003
AMD 1984 - 1989
Xerox PARC 1979 - 1984
Intel Corporation January 1977 - 1979
Skills
Medical Devices, Product Development, Semiconductors, Reliability, Signal Processing, Design Control, Ultrasound, R&D, Biomedical Engineering, Patents, IC, FDA, Medical Imaging, ISO 13485, Cross-functional Team..., Image Processing, FEM Modeling, Multidisciplinary Design, Reliability Engineering, Production Process..., Sensors
Education
Stanford University 1975 — 1977
MS+ Follow On PhD Coursework, Materials Science and Engineering, 3.82/4.00
Northeastern University 1971 — 1975
Bachelor's Degree, Mechanical Engineering, 3.84/4.00, Deans List all years
Solidscape inc July 2014 - Present
St. Jude Medical March 2012 - Present
LightLab Imaging November 2008 - March 2012
Palomar Medical Products September 2001 - September 2008
Visualization Technology Incorporated July 2000 - September 2001
Communications and Power Ind January 1998 - July 2000
Skills
Medical Devices, Design Control, ISO 13485, Engineering, FDA, Test Process Development, Design Verification..., Optical Engineering, Manufacturing..., Manufacturing..., Manufacturing, Product Development, PCB design, Electronics, Testing, R&D, LabVIEW, Six Sigma, Troubleshooting
Education
Northeastern University 1998 — 2000
Electrical and Electronics Engineering
USMC 1994 — 1998
Associate's degree, Electronics
Wendy's Wee Wears January 2013 - Present
Retirement's R US August 2012 - Present
St. Jude Medical July 2001 - August 2012
Ela Medical June 1999 - April 2001
Boston Scientific /Schneider June 1993 - April 1999
Cardiac Pacemakers Inc. ELI LILLY 1988 - 1989
Skills
FDA, ISO 13485, CAPA, Medical Devices, Quality System, SPC, Inspection, Root Cause Analysis, V&V, ISO, Validation, Sop, Design Control, R, ISO 14971, Quality Auditing, DMAIC, Quality Control, Quality Assurance, Gage R, Iso 9000, 21 CFR, FDA GMP, 21 CFR Part 11, Design for Manufacturing, Biomedical Engineering, CQA, Regulatory Affairs, Manufacturing, 5S, GLP, Cross-functional Team..., Injection Molding, PMA, CE marking, CQE, Catheters, Biocompatibility, Testing, Computer System..., Molding, Process Engineering, Kaizen, GxP, Software Documentation, FMEA, Supplier Quality, Change Control, Continuous Improvement, Six Sigma
Education
North Hennepin Community College
Forum Pharmaceuticals Inc. 2013 - Present
Boston Scientific 2007 - 2012
Boston Scientific 2004 - 2007
Medtronic 1998 - 2004
St. Jude Medical 1995 - 1998
Sulzer Intermedics 1991 - 1995
Skills
Cardiovascular Devices, Clinical Research, Clinical Trials, CTMS, EDC, FDA, GCP, ISO 14971, Managing Project Budgets, Medical Devices, Microsoft Office, MS Project, Project Management, Trial Management, Visio, Cardiology, Clinical Monitoring, Interventional..., CRO, Protocol, Therapeutic Areas, Clinical Study Design, Regulatory Submissions
Education
Northeastern University
Master of Science (M.S.), Technical Communication
Texas A&M University
Bachelor of Science (B.S.), Bioengineering
University of Minnesota-Twin Cities
Psychology
St Jude Medical February 2015 - Present
St. Jude Medical March 2014 - February 2015
ATMI January 2012 - March 2014
ATMI June 2009 - January 2012
Siemens Healthcare 2008 - 2009
Mayo Clinic 2003 - 2008
Skills
Biotechnology, Quality System, Validation, FDA, CAPA
Education
North Dakota State University 1998 — 2002
Microbiology
St. Jude Medical June 2015 - Present
St. Jude Medical June 2014 - May 2015
Bellisio Foods, Inc. August 2013 - June 2014
St. Jude Medical January 2011 - August 2013
St. Jude Medical March 2007 - January 2011
St. Jude Medical January 2005 - March 2007
St. Jude Medical December 2000 - January 2005
St. Jude Medical June 1999 - December 2000
Honeywell 1992 - 1999
Minnesota Power 1992 - 1992
Skills
SAP, Six Sigma, Cross-functional Team..., Analysis, Leadership, ERP, Procurement, Management, Continuous Improvement, Strategic Planning, Vendor Management, Process Improvement, Data Migration, Logistics, Testing, Supply Chain, Manufacturing, Project Management, Master Data Management
Education
Northern Illinois University 1995 — 1999
MBA
University of Minnesota Duluth 1989 — 1992
BAc
St. Cloud State University 1987 — 1989
Ridgewater College 1984 — 1986
Technical
University of St. Thomas
Professional Development
St. Jude Medical September 2011 - November 2012
Minneapolis Public Schools 2007 - 2007
ADC Telecommunications 2006 - 2007
General Mills February 2001 - May 2002
Metris Companies 1999 - 2000
Johnson Matthey Electronics, Inc 1999 - 1999
ADC Telecommunications Inc 1996 - 1999
Northrup King 1989 - 1996
Skills
SAP, SAP HR, ERP, SAP R/3, Business Analysis, Business Intelligence, Process Improvement, ECC, SAP Implementation, HRIS, SAP ERP, Human Resources, SAP Netweaver, Payroll
Education
Northern Illinois University
MBA
Syracuse University
B.S., Computer Science
St. Jude Medical April 2013 - Present
Second Sight Medical Products May 2012 - March 2013
Second Sight Medical Products March 2010 - May 2012
Amgen 2006 - 2008
Skills
Biomedical Engineering, Design Control, FDA, Biotechnology, Medical Devices, CAPA, GMP, Microfabrication, Matlab, Quality System, Manufacturing, V&V, R&D, Testing
Education
University of Southern California 2008 — 2009
Master of Science, Biomedical Engineering
Northwestern University 2002 — 2006
Bachelor of Science, Biomedical Engineering
Creganna Tactx Medical February 2014 - Present
St. Jude Medical February 2013 - December 2013
St. Jude Medical November 2009 - November 2012
Transoma Medical Inc. 2001 - April 2009
ATS Medical, Inc. June 1999 - January 2001
Boston Scientific /Schneider 1984 - 1999
Skills
Product Specification, Medical Devices, FDA, V&V, ISO 13485, CAPA, Design Control, Quality System, Design of Experiments, Validation, Lean Manufacturing, Manufacturing, Continuous Improvement, Process Improvement, Testing, Quality Assurance, Solidworks, R&D, FMEA, Minitab, SPC, Biomedical Engineering, Process Simulation, ISO 14971, Design for Manufacturing
Education
North Hennepin Community College 1987 — 1988
No, Business Management
St. Jude Medical November 2010 - Present
Education
University of Minnesota - Carlson School of Management 2007 — 2009
MS, Management of Technology
Northwestern University 1992 — 1996
BS, Biomedical Engineering
Philips Healthcare March 2010 - Present
Radi Medical Systems AB July 2004 - June 2009
St. Jude Medical 2009 - 2009
Fantini Baking Company, Inc. March 1991 - April 2004
Skills
Invoicing, Customer Service, Microsoft Excel, Accounts Receivable, QuickBooks, SAP, Operating Room, Accounts Payable, Capital Equipment, Software Documentation, Cardiology, Administration
Education
Northern Essex Community College 1994 — 1995
Accounting
St. Jude Medical February 2013 - Present
St. Jude Medical February 2013 - February 2014
Amgen July 2012 - September 2012
Skills
FDA, Regulatory Affairs, Biotechnology, GMP, Medical Devices
Education
Northeastern University
Masters, Regulatory Affairs
Wageningen University, The
Masters, Medical Biotechnology
Osmania University
Bachelors, Biotechnology & Bio-Informatics
St Jude Medical July 2007 - Present
St. Jude Medical July 2010 - August 2011
US Navy August 2003 - August 2007
US Navy January 1999 - August 2007
Skills
Medical Devices, Product Development, Cross-functional Team..., Process Improvement, FDA, R&D, Product Launch, Capital Equipment, Six Sigma, Market Development, Cardiology, Medical Imaging, Validation, Continuous Improvement
Education
Naval School of Health Sciences
Associate of Science (A.S.), Cardiopulmonary Technology/Technologist
Northwestern College
Chemistry
St. Jude Medical May 2009 - Present
St. Jude Medical April 2009 - Present
Skills
Medical Devices, Project Management, Healthcare, Cross-functional Team..., FDA, Product Development, Hospitals, Quality System, Sales Operations, R&D, Validation, Process Improvement, Manufacturing
Education
Hennepin Technical college 2011 — 2016
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
North Hennepin Community College
St. Jude Medical August 2000 - Present
St. Jude Medical Cardiovascular Division 2000 - Present
Boston Scientific February 1989 - April 2000
Prudential Insurance March 1983 - September 1987
Education
North Hennepin Community College 1980 — 1983
St. Jude Medical January 2011 - Present
LightLab Imaging July 2008 - Present
Analogic January 1992 - July 1996
Skills
Firmware, Design Control, Medical Devices, Hardware, Design for Manufacturing, Biomedical Engineering, C, C++, ISO 13485, Embedded Systems, FDA, Microsoft SQL Server, R&D, Signal Processing, Digital Imaging, Design of Experiments, Testing, CAPA
Education
Northeastern University 1996 — 2002
Doctor of Philosophy (Ph.D.), Computer Science
Mirea 1986 — 1991
Massachusetts General Hospital February 2007 - Present
St. Jude Medical February 1990 - May 2002
Skills
Medical Devices, Medical Imaging, Biomedical Engineering, Healthcare Information..., Healthcare, Hospitals, Capital Equipment, Management, Team Building, Process Improvement, Cross-functional Team..., Leadership, Strategic Planning
Education
Northeastern University 1980 — 1986
Maquet Cardiovascular September 2013 - Present
Hansen Medical April 2012 - September 2013
St. Jude Medical September 2004 - April 2012
St. Jude Medical July 2003 - September 2004
Skills
Medical Devices, Biomedical Engineering, R&D, Design Control, FDA, Pacemakers, Clinical Research, ISO 13485, Electrophysiology, Product Development, Validation, Cardiology, Heart Failure, V&V, Design of Experiments, Clinical Trials, Signal Processing, Systems Engineering, Hardware Diagnostics, Medical Device R&D, Invention, Technical Leadership, Data Analysis, CAPA, Cardiac, Matlab, Research, Product Design, Human Factors, System Requirements, Patents, Surgical Instruments, Experimentation, Algorithm Design, CE marking, Clinical, Diagnostics, Medical Device Product..., Risk Analysis, Publications, Customer Research, Usability Testing, Technical Writing, Prototyping, Peripheral Vascular, Robotic Surgery, Robotic Catheter, ICDs, CRTs, Medical System...
Education
Northwestern University
PhD, Biomedical Engineering
St. Jude Medical August 2015 - Present
St. Jude Medical February 2013 - August 2015
Draeger May 2012 - November 2012
Med-Pharmex, Inc. October 2011 - December 2011
Skills
Regulatory Affairs, Drug Development, Pharmacology, Medical Devices, Pharmaceutics, Clinical Data Management, PMA, FDA, ISO 13485, CAPA, Regulatory Requirements, ISO 14971, GMP, eCTD, NDA, Regulatory Submissions, CFG, Apostille, 21 CFR, Quality System, Clinical Trials, Pharmacovigilance, IND, Biotechnology, Product Development, STED Writting, CE marking, Quality Assurance, 21 CFR Part 11, Design Control, Medical Device Directive
Education
Northeastern University 2010 — 2012
M.Sc Regulatory Affairs
University of Mumbai 2006 — 2010
Bachelor of Pharmacy
Heraeus Medical Components August 2011 - Present
Wilson Tool International April 2005 - October 2011
HEI Inc December 1997 - February 2005
Seagate Technology 1993 - 1996
Nortronics 1981 - 1985
St. Jude Medical 1980 - 1981
Johnson and Johnson MD&D 1976 - 1980
Skills
SAP IN/MM/PP, Inventory Control, SAP, Supply Chain Management, Lean Manufacturing, Manufacturing, Continuous Improvement, Six Sigma, Process Improvement, Budgets, Operations Management, Supply Chain, Inventory Management, Root Cause Analysis, 5S, Process Engineering, Kanban, Warehousing, Logistics, Kaizen, Troubleshooting, Purchasing, Cross-functional Team..., Manufacturing..., Sourcing, Value Stream Mapping, Team Building, Production Planning
Education
North Hennepin Community College 2000 — 2004
CPIM, Production and Inventory Control
Hennepin County Medical Center October 2014 - Present
CHS September 2012 - May 2014
Ameriprise Financial Services, Inc. October 2011 - March 2012
St. Jude Medical January 2011 - May 2011
CHS October 2010 - November 2010
St. Jude Medical October 2009 - April 2010
Ceridian Corporation January 2000 - January 2009
Super Valu January 1999 - January 2000
Centura Health January 1998 - January 1999
Multifoods Specialty Distribution January 1994 - January 1998
Skills
Deferred Compensation, HRIS, Human Resources, Executive Pay, Incentive Programs, Salary, Job Evaluation, Job Descriptions, Personnel Management, Compensation & Benefit, Training, FLSA, Talent Acquisition, Employee Relations, Benefits Administration
Education
Northern Arizona University 1991 — 1993
BSBA, Human Resources
Northern Arizona University
B.S, Human Resource Management; Business Administration
Enphase Energy June 2014 - Present
Lumenous Device Technologies Inc. October 2013 - March 2014
C.E. Niehoff September 2012 - October 2013
C.E. Niehoff June 2010 - September 2012
Northwestern University September 2009 - July 2010
Daily Northwestern October 2005 - December 2009
US Steel June 2008 - September 2008
Medtronic June 2007 - September 2007
St. Jude Medical June 2006 - September 2006
Skills
Mechanical Engineering, Pro Engineer, Product Development, Materials, SolidWorks, PTC Creo, Unigraphics, Product Design, Microsoft Office, Pro/Engineer, Minitab, SmartCAM, Laser Cutting, Moldflow, Technical Writing, Injection Molding, Mechanical Product..., Project Management
Education
Northwestern University 2009 — 2010
MS, Mechanical Engineering
Northwestern University 2005 — 2009
BS, Materials Science and Engineering
Queen Mary University of London 2007 — 2008
Lutonix,Inc. (a Subsidiary of C.R. Bard) October 2013 - Present
Lutonix, Inc. (a Subsidiary of C.R. Bard) January 2009 - October 2013
St. Jude Medical January 2004 - September 2008
Velocimed, Inc. February 2001 - January 2004
Sulzer IntraTherapeutics, Inc. January 2000 - November 2001
Sulzer IntraTherapeutics, Inc. January 1998 - 2000
Skills
Medical Devices, Software Documentation, FDA, ISO 13485, Quality System
Education
North Hennepin Community College
AA, Associate of Arts/Business
St. Jude Medical Clinical Support SpecialistBIOTRONIK2008 - August 2009
Skills
Medical Devices
Education
Northern Michigan University 1987 — 1994
BSA, Health & Fitness Management
Boston Scientific June 2011 - Present
St. Jude Medical August 1999 - June 2011
St. Jude Medical March 1998 - July 1999
Ventritex November 1995 - February 1997
Medtronic November 1991 - October 1995
US Navy June 1987 - June 1991
Skills
Interventional..., Hospitals, Clinical Research, Operating Room, Medical Devices, Cardiology, Cath Lab, Start-ups, Team Building, Market Development, Product Launch, Cross-functional Team..., Surgery, Pacemakers
Education
Webster University 1998 — 2001
MA, Business and Management
Northwestern University 1983 — 1987
BS, Biomedical Engineering
St. Jude Medical May 2012 - July 2014
Haemonetics March 2008 - November 2011
Haemonetics 2001 - 2008
Haemonetics September 2000 - December 2001
Transfusion Technologies Corp 1996 - 2000
Kendall Healthcare 1991 - 1996
Kendall Healthcare 1983 - 1991
Skills
Lean Manufacturing, Six Sigma Green Belt, Project Planning, Change Management, Quality Systems, Corrective Action, Product Development, Contract Manufacturing
Education
Northwestern University 1974 — 1977
MS, Biomedical Engineering
Northwestern University 1970 — 1974
BS, Biomedical Engineering
LSA Laser November 2014 - Present
Medtronic May 2014 - November 2014
St. Jude Medical July 2007 - May 2014
St. Jude Medical 2004 - 2007
FarNorth Windows and Doors 2003 - 2004
Aveda 1997 - 2003
Minnesota National Guard 1989 - 1998
Advantek 1994 - 1997
Education
University of Minnesota-Crookston
Bachelors, Manufacturing Management
North Hennepin Community College
St. Jude Medical 2009 - Present
Foxhollow Technologies 2004 - 2008
Education
Northeastern University 1993 — 1995
MS, Physiology
Springfield College 1988 — 1992
BS, Exercise Science
St Jude Medical 2009 - Present
Skills
Medical Devices, Cardiology, Product Launch, Troubleshooting, Urology, Cross-functional Team..., Quality Assurance, Process Improvement, Orthopedic, Software Documentation, Pharmaceutical Sales, Sales Operations, Healthcare, Technical Support, Six Sigma, Orthopedics, Vascular
Education
University of Kentucky 1978 — 1980
Master of Science (MS), Physician Assistant
Northern Kentucky University
Associate Degree Applied Science, Registered Nursing/Registered Nurse
UCI Medical Affiliates November 2011 - Present
St. Jude Medical October 2008 - November 2011
Boston Medical Center January 2007 - August 2008
Education
Northeastern University 1996 — 2000
BSN, Nursing
Northeastern University
AD, Radiological Technology
Graduate of Northwestern College 2007 - 2011
Boston Scientific March 2006 - March 2010
St. Jude Medical May 2004 - March 2006
Eli Lilly and Company January 1983 - April 2004
Skills
FMLA, HRIS, Employee Relations, HR Policies, Onboarding, Unemployment Claims, EEO, Deferred Compensation, Job Descriptions, Open Enrollment
Education
Northwestern College 2007 — 2011
BS, Human Resource Management
Cardiovascular Systems Inc June 2013 - Present
Bicon Dental Implants July 2011 - June 2013
St. Jude Medical September 2009 - February 2011
ND Landscape, Inc June 2007 - January 2010
Skills
Healthcare, Direct Sales, Customer Relations, Team Leadership, Pre-sales Technical..., Post-sales Support, Customer Service, Training, Leadership, Account Management, Marketing, Sales Management, Sales Operations, Surgeons
Education
Northeastern University 2006 — 2011
Bachelor of Science Degree, Economics
St. John’s Prepatory 2003 — 2006
Stifel Financial Corp. January 2015 - Present
Scotiabank Global Banking and Markets January 2014 - June 2014
Goldman Sachs January 2013 - June 2013
PwC January 2012 - May 2012
St. Jude Medical May 2011 - August 2011
Zhang & Associates, P.C. July 2009 - August 2009
Congressional Office of Congressman Nick Lampson June 2008 - August 2008
Education
Northeastern University 2010 — 2015
Bachelor of Science in Business Administration (B.S.B.A.), Finance and Accounting
London School of Economics and Political Science 2012 — 2012
St. Jude Medical August 2014 - Present
Chandra labs August 2011 - March 2012
Merck-Sharp and Dohme Pharmaceuticals December 2010 - July 2011
Skills
Documentation, Microsoft Office, Management, CAPA, Medical Devices, Microsoft Excel, Microsoft Word, Customer Service, Quality Assurance, Analysis
Education
Northeastern University 2012 — 2014
Northeastern University
Northeastern University
Master of Science, Regulatory Affairs for Drugs, Biologics and Medical Devices
St. Jude Medical June 2009 - Present
McKesson August 2006 - June 2009
Cornerstone March 2005 - August 2006
Skills
Medical Devices, Cardiology, Operating Room, Capital Equipment, Orthopedic, Hospitals, Surgery, Vascular, Healthcare, Surgeons, Neuromodulation, Pharmacueticals, Sales, Spine, Medical Sales, Capital Equipment Sales, Disposables, General Surgery, Managed Care, Market Development, Neurology, Neurosurgery, Radiology, Sales Operations, Surgical Instruments, ENT, Vascular Surgery, Wound Care
Education
Northwestern State University 2002 — 2004
Bachelor of Science (BS), Registered Nursing/Registered Nurse, 4.0
Northwestern State University 1997 — 2000
Associate of Science (A.S.), Registered Nursing/Registered Nurse
St. Jude Medical May 2014 - Present
St. Jude Medical April 2013 - May 2014
AorTech Polymers and Medical Devices September 2011 - April 2013
Minnesota Outdoor Heritage Alliance April 2011 - September 2011
Hirshfield's Paint Manufacturing March 1997 - March 2011
Skills
Process Safety, Outlook, GMP, Microsoft Office, Microsoft Excel, Inventory Management, Process Improvement, Customer Service, Manufacturing, Team Building, Product Development, Troubleshooting, Cross-functional Team..., Nonprofits
Education
North Hennepin Community College 1991 — 1992
Law Enforcement
St. Cloud Technical College 1990 — 1991
Certificate, Emergency Medical Technology/Technician (EMT Paramedic)
St. Jude Medical January 1996 - Present
Education
University of Iowa 1990 — 1993
Bachelor of Arts (B.A.), Sociology
Northern Arizona University 1989 — 1990
St. Jude Medical April 2011 - Present
Johnson & Johnson July 2009 - April 2011
Education
Northwestern University
Bachelor of Science (B.S.), Communications
St. Jude Medical June 2013 - Present
Education
North Lake College