St. Jude Medical-CRMD
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St. Jude Medical-CRMD Employees
Employee
Years
Job
Industry
Katherine Talbert Katherine Talbert's St. Jude Medical-CRMD Experience 2008 - 2014
Job Associate at Suttons Creek, Inc.
Industry Medical Devices
Experience
Suttons Creek, Inc. November 2014 - Present
St. Jude Medical, CRMD 2008 - 2014
St. Jude Medical 2002 - 2008
St. Jude Medical 1999 - 2002
Litton Data Systems 1992 - 1999
Librascope 1989 - 1992
Skills
Software Project..., Cross-functional Team..., Software Development, Scrum, ISO 13485, Medical Devices, IEC 62304, SDLC, Continuous Integration, Security, Software Quality..., CAPA, FDA, Requirements Analysis, Object Oriented Design, V&V, Quality Assurance, Quality System, Software Requirements, Software Engineering, R&D, Testing, Embedded Software, Program Management, Requirements Management, Validation, Process Improvement, Leadership, Software Design, Product Development, Agile Project Management, Project Management, Management, Technical Leadership, Agile Methodologies, System Requirements, System Testing, Software Documentation, Configuration Management, ClearQuest, Telelogic DOORS, Biomedical Engineering, Commercialization, ClearCase, Requirement..., MS Office, MS Project, Microsoft Project
Education
University of California, Los Angeles
BS, Computer Engineering
Suttons Creek, Inc. November 2014 - Present
St. Jude Medical, CRMD 2008 - 2014
St. Jude Medical 2002 - 2008
St. Jude Medical 1999 - 2002
Litton Data Systems 1992 - 1999
Librascope 1989 - 1992
Skills
Software Project..., Cross-functional Team..., Software Development, Scrum, ISO 13485, Medical Devices, IEC 62304, SDLC, Continuous Integration, Security, Software Quality..., CAPA, FDA, Requirements Analysis, Object Oriented Design, V&V, Quality Assurance, Quality System, Software Requirements, Software Engineering, R&D, Testing, Embedded Software, Program Management, Requirements Management, Validation, Process Improvement, Leadership, Software Design, Product Development, Agile Project Management, Project Management, Management, Technical Leadership, Agile Methodologies, System Requirements, System Testing, Software Documentation, Configuration Management, ClearQuest, Telelogic DOORS, Biomedical Engineering, Commercialization, ClearCase, Requirement..., MS Office, MS Project, Microsoft Project
Education
University of California, Los Angeles
BS, Computer Engineering
James Quen James Quen's St. Jude Medical-CRMD Experience January 2006 - December 2010
Job Tools Engineer
Industry Medical Devices
Experience
Misfit Wearables January 2015 - Present
St. Jude Medical March 2014 - January 2015
St. Jude Medical AFD December 2010 - January 2014
St. Jude Medical CRMD January 2006 - December 2010
Skills
C#, C++, Objective-C, XML, Xcode, Software Engineering, Object Oriented Design, C, Linux, Cocoa Touch, Unit Testing
Education
San Jose State University 2001 — 2005
Bachelor of Science, Electrical Engineering
Misfit Wearables January 2015 - Present
St. Jude Medical March 2014 - January 2015
St. Jude Medical AFD December 2010 - January 2014
St. Jude Medical CRMD January 2006 - December 2010
Skills
C#, C++, Objective-C, XML, Xcode, Software Engineering, Object Oriented Design, C, Linux, Cocoa Touch, Unit Testing
Education
San Jose State University 2001 — 2005
Bachelor of Science, Electrical Engineering
Umesh Shah Umesh Shah's St. Jude Medical-CRMD Experience November 2007 - September 2012
Job Project Manager, Development Quality at St. Jude Medical, CQE
Industry Medical Devices
Experience
St. Jude Medical October 2014 - Present
St. Jude Medical September 2012 - Present
St. Jude Medical, CRMD November 2007 - September 2012
Medtronic Minimed June 2006 - November 2007
DEX 2005 - 2006
Skills
Design Verification..., ISO 13485, IEC 60601, Design of Experiments, Validation, Part 820, Risk Management, DFMEA, PFMEA, Quality Assurance, Design Assurance, Quality Management, Test Methodologies, Medical Devices, Design Control, Product Development, R&D, ISO 14971, EMI, Safety, Class III Medical..., CAPA, Quality Auditing, CE marking, Reliability, Medical Compliance, Testing, Quality Control, Pro Engineer, V&V, Design for Manufacturing, Quality System, Biomedical Engineering, FMEA, Six Sigma, Embedded Systems, FDA, Data Structures, Root Cause Analysis, 21 CFR, DMAIC, SPC, Process Capability, Gage R&R, Biomaterials, 21 CFR Part 11, Failure Analysis, Supplier Quality
Education
California State University-Northridge 2005 — 2007
Sardar Patel University
St. Jude Medical October 2014 - Present
St. Jude Medical September 2012 - Present
St. Jude Medical, CRMD November 2007 - September 2012
Medtronic Minimed June 2006 - November 2007
DEX 2005 - 2006
Skills
Design Verification..., ISO 13485, IEC 60601, Design of Experiments, Validation, Part 820, Risk Management, DFMEA, PFMEA, Quality Assurance, Design Assurance, Quality Management, Test Methodologies, Medical Devices, Design Control, Product Development, R&D, ISO 14971, EMI, Safety, Class III Medical..., CAPA, Quality Auditing, CE marking, Reliability, Medical Compliance, Testing, Quality Control, Pro Engineer, V&V, Design for Manufacturing, Quality System, Biomedical Engineering, FMEA, Six Sigma, Embedded Systems, FDA, Data Structures, Root Cause Analysis, 21 CFR, DMAIC, SPC, Process Capability, Gage R&R, Biomaterials, 21 CFR Part 11, Failure Analysis, Supplier Quality
Education
California State University-Northridge 2005 — 2007
Sardar Patel University
Madhu Karnani Oza Madhu Karnani Oza's St. Jude Medical-CRMD Experience April 2008 - February 2009
Job Senior Manager, Remote Care Operations at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical October 2012 - Present
St. Jude Medical April 2008 - October 2012
St. Jude Medical September 2005 - February 2010
St. Jude Medical August 2005 - December 2009
St. Jude Medical-CRMD April 2008 - February 2009
Tucker-Davis Technologies June 2003 - August 2005
Tucker-Davis Technologies June 2003 - August 2005
Skills
Medical Devices, FDA, Biomedical Engineering, R&D, Product Development, Cross-functional Team..., Six Sigma
Education
University of Wisconsin-Madison 2001 — 2003
MS, Biomedical Engineering
University of Wisconsin
Master of Science, Biomedical Engineering
University of Mumbai 1997 — 2001
B.E, Biomedical Engineering
University of Mumbai
Bachelor of Engineering, Biomedical Engineering
St. Jude Medical October 2012 - Present
St. Jude Medical April 2008 - October 2012
St. Jude Medical September 2005 - February 2010
St. Jude Medical August 2005 - December 2009
St. Jude Medical-CRMD April 2008 - February 2009
Tucker-Davis Technologies June 2003 - August 2005
Tucker-Davis Technologies June 2003 - August 2005
Skills
Medical Devices, FDA, Biomedical Engineering, R&D, Product Development, Cross-functional Team..., Six Sigma
Education
University of Wisconsin-Madison 2001 — 2003
MS, Biomedical Engineering
University of Wisconsin
Master of Science, Biomedical Engineering
University of Mumbai 1997 — 2001
B.E, Biomedical Engineering
University of Mumbai
Bachelor of Engineering, Biomedical Engineering
Paul Edney Paul Edney's St. Jude Medical-CRMD Experience January 2005 - January 2006
Job CEO, The SOAHC Group, Inc.
Industry Medical Devices
Experience
The SOAHC Group May 2009 - Present
Becton, Dickinson and Company December 2010 - June 2014
Covidien June 2008 - May 2009
Covidien July 2007 - September 2008
Roche Diagnostics January 2006 - July 2007
St. Jude Medical, CRMD January 2005 - January 2006
University of Chicago Graduate School of Business 2003 - 2005
IDM Images de Marque SA 1990 - 2003
Northwestern University 1996 - 2002
ETH Zurich 1995 - 1996
Skills
Strategy, Program Management, Leadership, Product Development, Strategic Planning, Six Sigma, Management, Start-ups, Integration, Medical Devices, Lean Manufacturing, Manufacturing, FDA, R&D, Business Development, Team Building, Engineering, Commercialization, Product Management, Mergers & Acquisitions, Market Research, Risk Management, Product Launch, ISO 13485, Systems Engineering, Biomedical Engineering, Strategic Technology..., Cross-functional Team..., Innovation, Product Design, Market Development, Design Control, Quality System, Engineering Management
Education
Northwestern University 1996 — 2002
Ph.D., Biomedical Engineering (applied physics)
The University of Chicago Booth School of Business 1999 — 2000
MBA, General Management, Strategic Management, Marketing Management
Eidgenössische Technische Hochschule Zürich 1989 — 1995
M.S. (Diploma), Physics (High-Energy Physics, Medical Physics)
Harvard Business School 2008 — 2008
Certificate, Intellectual Property
Gymnase Cantonal du Bugnon 1986 — 1989
Maturité Fédérale, Mathematics and Sciences (Type C)
Startup Institute 2014 — 2014
Sales and Account Management
The SOAHC Group May 2009 - Present
Becton, Dickinson and Company December 2010 - June 2014
Covidien June 2008 - May 2009
Covidien July 2007 - September 2008
Roche Diagnostics January 2006 - July 2007
St. Jude Medical, CRMD January 2005 - January 2006
University of Chicago Graduate School of Business 2003 - 2005
IDM Images de Marque SA 1990 - 2003
Northwestern University 1996 - 2002
ETH Zurich 1995 - 1996
Skills
Strategy, Program Management, Leadership, Product Development, Strategic Planning, Six Sigma, Management, Start-ups, Integration, Medical Devices, Lean Manufacturing, Manufacturing, FDA, R&D, Business Development, Team Building, Engineering, Commercialization, Product Management, Mergers & Acquisitions, Market Research, Risk Management, Product Launch, ISO 13485, Systems Engineering, Biomedical Engineering, Strategic Technology..., Cross-functional Team..., Innovation, Product Design, Market Development, Design Control, Quality System, Engineering Management
Education
Northwestern University 1996 — 2002
Ph.D., Biomedical Engineering (applied physics)
The University of Chicago Booth School of Business 1999 — 2000
MBA, General Management, Strategic Management, Marketing Management
Eidgenössische Technische Hochschule Zürich 1989 — 1995
M.S. (Diploma), Physics (High-Energy Physics, Medical Physics)
Harvard Business School 2008 — 2008
Certificate, Intellectual Property
Gymnase Cantonal du Bugnon 1986 — 1989
Maturité Fédérale, Mathematics and Sciences (Type C)
Startup Institute 2014 — 2014
Sales and Account Management
Courtney Sheffield Courtney Sheffield's St. Jude Medical-CRMD Experience March 2011 - September 2011
Job Mechanical Engineer at VTS Medical Systems, a WhollyOwned Subsidiary of STERIS Corporation
Industry Mechanical or Industrial Engineering
Experience
VTS Medical Systems, a Wholly-Owned Subsidiary of STERIS Corporation January 2013 - Present
VTS Medical Systems, LLC June 2012 - December 2012
St. Jude Medical CRMD March 2011 - September 2011
Skills
Solidworks, Rapid Prototyping, Matlab, Engineering, PTC Pro/Engineer, Composites, Fixture Design, Test Design, R&D
Education
California Polytechnic State University-San Luis Obispo 2008 — 2012
BS, Mechanical Engineering, 3.495
Santa Rosa Junior College 2009 — 2009
General Education, GPA 4.0
Windsor High School 2004 — 2008
High School Diploma, 4.44 GPA
VTS Medical Systems, a Wholly-Owned Subsidiary of STERIS Corporation January 2013 - Present
VTS Medical Systems, LLC June 2012 - December 2012
St. Jude Medical CRMD March 2011 - September 2011
Skills
Solidworks, Rapid Prototyping, Matlab, Engineering, PTC Pro/Engineer, Composites, Fixture Design, Test Design, R&D
Education
California Polytechnic State University-San Luis Obispo 2008 — 2012
BS, Mechanical Engineering, 3.495
Santa Rosa Junior College 2009 — 2009
General Education, GPA 4.0
Windsor High School 2004 — 2008
High School Diploma, 4.44 GPA
Emily Wann, PMP Emily Wann, PMP's St. Jude Medical-CRMD Experience October 2000 - May 2003
Job PMO Director at Department of Revenue State of Indiana
Industry Information Technology and Services
Experience
Department of Revenue at State of Indiana June 2013 - Present
Apparatus June 2011 - June 2013
Dittoe PR 2010 - 2011
Core BTS March 2009 - June 2010
Core BTS September 2007 - September 2008
Sallie Mae May 2003 - August 2007
St. Jude Medical, CRMD October 2000 - May 2003
St Jude Medical 2000 - 2003
EDS 1998 - 2003
Skills
Management, Vendor Management, SharePoint, CRM, Program Management, Strategic Planning, PMO, Contract Negotiation, Training, Enterprise Software, Strategy, Business Development, SDLC, Salesforce.com, Account Management, Business Intelligence, Project Management, New Business Development, Information Technology, Data Center, IT Strategy, SaaS, Integration, Cloud Computing, Enterprise Architecture
Education
Indiana University-Purdue University at Indianapolis 1993 — 1996
Department of Revenue at State of Indiana June 2013 - Present
Apparatus June 2011 - June 2013
Dittoe PR 2010 - 2011
Core BTS March 2009 - June 2010
Core BTS September 2007 - September 2008
Sallie Mae May 2003 - August 2007
St. Jude Medical, CRMD October 2000 - May 2003
St Jude Medical 2000 - 2003
EDS 1998 - 2003
Skills
Management, Vendor Management, SharePoint, CRM, Program Management, Strategic Planning, PMO, Contract Negotiation, Training, Enterprise Software, Strategy, Business Development, SDLC, Salesforce.com, Account Management, Business Intelligence, Project Management, New Business Development, Information Technology, Data Center, IT Strategy, SaaS, Integration, Cloud Computing, Enterprise Architecture
Education
Indiana University-Purdue University at Indianapolis 1993 — 1996
Krista Jones's St. Jude Medical-CRMD Experience March 1999 - October 2011
Job Senior Financial Analysis at US HealthWorks
Industry Accounting
Experience
US HealthWorks April 2013 - Present
Ledgent Staffing January 2012 - April 2013
St. Jude Medical CRMD March 1999 - October 2011
PPI Wholesale, Inc October 1997 - February 1999
Aon Albert G. Ruben February 1988 - October 1997
Skills
SAP Super User, Microsoft Excel, Microsoft Word, General Ledger..., Fixed Assets, Intercompany Accounting, Journal Entries and..., Commissions, Attention To Detail, Month End Close, Excellent written and..., Commissioned Art, Super User, Journal Entries, Accounting, Accruals, General Ledger, Account Reconciliation, Access, Communication, Accounts Payable, Financial Reporting, Financial Analysis, Process Improvement, Management, Financial Statements, Outlook, Human Resources, Accounts Receivable, Budgets, Auditing, Finance, Forecasting, GAAP, Hyperion Enterprise, Invoicing, Sarbanes-Oxley Act, Variance Analysis
Education
California State University
Bachelor of Science Degree, Business Administration
Pierce College
Associates of Science Degree, Business Administration
US HealthWorks April 2013 - Present
Ledgent Staffing January 2012 - April 2013
St. Jude Medical CRMD March 1999 - October 2011
PPI Wholesale, Inc October 1997 - February 1999
Aon Albert G. Ruben February 1988 - October 1997
Skills
SAP Super User, Microsoft Excel, Microsoft Word, General Ledger..., Fixed Assets, Intercompany Accounting, Journal Entries and..., Commissions, Attention To Detail, Month End Close, Excellent written and..., Commissioned Art, Super User, Journal Entries, Accounting, Accruals, General Ledger, Account Reconciliation, Access, Communication, Accounts Payable, Financial Reporting, Financial Analysis, Process Improvement, Management, Financial Statements, Outlook, Human Resources, Accounts Receivable, Budgets, Auditing, Finance, Forecasting, GAAP, Hyperion Enterprise, Invoicing, Sarbanes-Oxley Act, Variance Analysis
Education
California State University
Bachelor of Science Degree, Business Administration
Pierce College
Associates of Science Degree, Business Administration
Tobias Cajamarca's St. Jude Medical-CRMD Experience July 2010 - August 2011
Job Research & Development Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical - CATD March 2013 - Present
St. Jude Medical - CVD January 2012 - March 2013
Teleflex Medical OEM August 2011 - January 2012
St. Jude Medical - CRMD July 2010 - August 2011
St. Jude Medical - CRMD March 2008 - July 2010
St. Jude Medical - CRMD June 2005 - March 2008
St. Jude Medical - AFD February 2000 - June 2005
St. Jude Medical - DAIG division April 1998 - February 2000
Skills
Medical Devices, Product Development, Manufacturing, Continuous Improvement, Minitab, Solidworks, Six Sigma, Design for Manufacturing
Education
Saint Mary's University of Minnesota 2007 — 2011
B.S, Industrial Technology
Hennepin Technical College 2004 — 2007
A.A.S, Manufacturing Engineering Technology
Normandale Community College 2002 — 2004
General Education
Instituto Tecnológico Ricaurte de la ciudad de Cuenca-Ecuador 1986 — 1992
Electromechanical
St. Jude Medical - CATD March 2013 - Present
St. Jude Medical - CVD January 2012 - March 2013
Teleflex Medical OEM August 2011 - January 2012
St. Jude Medical - CRMD July 2010 - August 2011
St. Jude Medical - CRMD March 2008 - July 2010
St. Jude Medical - CRMD June 2005 - March 2008
St. Jude Medical - AFD February 2000 - June 2005
St. Jude Medical - DAIG division April 1998 - February 2000
Skills
Medical Devices, Product Development, Manufacturing, Continuous Improvement, Minitab, Solidworks, Six Sigma, Design for Manufacturing
Education
Saint Mary's University of Minnesota 2007 — 2011
B.S, Industrial Technology
Hennepin Technical College 2004 — 2007
A.A.S, Manufacturing Engineering Technology
Normandale Community College 2002 — 2004
General Education
Instituto Tecnológico Ricaurte de la ciudad de Cuenca-Ecuador 1986 — 1992
Electromechanical
Suzanne Kuric Suzanne Kuric's St. Jude Medical-CRMD Experience October 2000 - July 2004
Job Qualified Web Designer & Developer
Industry Internet
Experience
Suzanne Kuric Designs March 2011 - Present
Bernards January 2006 - October 2008
Vanir Construction Management May 2005 - December 2006
Howard Building Corporation August 2004 - March 2005
St. Jude Medical, CRMD October 2000 - July 2004
Skills
Web Design & Development, Article Writing, Artistic Talents
Education
Simi Valley Adult Center 2010 — 2011
Certificate, Web Development
FIDM 1980 — 1982
Associates of Art, Interior Design
California State University-Northridge 1978 — 1980
Suzanne Kuric Designs March 2011 - Present
Bernards January 2006 - October 2008
Vanir Construction Management May 2005 - December 2006
Howard Building Corporation August 2004 - March 2005
St. Jude Medical, CRMD October 2000 - July 2004
Skills
Web Design & Development, Article Writing, Artistic Talents
Education
Simi Valley Adult Center 2010 — 2011
Certificate, Web Development
FIDM 1980 — 1982
Associates of Art, Interior Design
California State University-Northridge 1978 — 1980
Lori Pope Lori Pope's St. Jude Medical-CRMD Experience May 1988 - June 2014
Job Director, Systems Engineering at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical June 2014 - Present
St. Jude Medical, CRMD May 1988 - June 2014
Skills
Design Control, Medical Devices, Biomedical Engineering, FDA, ISO 13485, R&D, Embedded Systems, Software Engineering, Agile Methodologies, Software Requirements, Software Verification, Regulatory Submissions, Object Oriented Design, Software Development, Systems Engineering, Signal Processing, Testing, Quality Assurance, ClearCase, Cross-functional Team..., Embedded Software, Patents, Commercialization, ClearQuest, System Architecture, Software Project..., Software Design, Technical Leadership, V&V, Validation, Product Development, Requirements Management, Test Automation, Scrum, ISO 14971, Quality System, Process Simulation, CAPA
Education
California State University-Northridge 1983 — 1987
B.S., Computer Science
St. Jude Medical June 2014 - Present
St. Jude Medical, CRMD May 1988 - June 2014
Skills
Design Control, Medical Devices, Biomedical Engineering, FDA, ISO 13485, R&D, Embedded Systems, Software Engineering, Agile Methodologies, Software Requirements, Software Verification, Regulatory Submissions, Object Oriented Design, Software Development, Systems Engineering, Signal Processing, Testing, Quality Assurance, ClearCase, Cross-functional Team..., Embedded Software, Patents, Commercialization, ClearQuest, System Architecture, Software Project..., Software Design, Technical Leadership, V&V, Validation, Product Development, Requirements Management, Test Automation, Scrum, ISO 14971, Quality System, Process Simulation, CAPA
Education
California State University-Northridge 1983 — 1987
B.S., Computer Science
Dingran Lu's St. Jude Medical-CRMD Experience January 2011 - July 2011
Job Algorithm Engineer at Masimo Corporation
Industry Medical Devices
Experience
Masimo Corporation August 2013 - Present
Masimo Corporation August 2012 - July 2013
California Polytechnic State University, San Luis Obispo March 2010 - March 2012
St. Jude Medical CRMD January 2011 - July 2011
Dayang Technology Development Inc. July 2008 - September 2008
Skills
Electrical Engineering, Matlab, Assembly, C, VHDL, Simulink, DSP, Python, Image Processing, Simulation, Microcontrollers, Artificial Neural..., FPGA, Pattern Recognition, Servo, MIPS, Fuzzy Logic, Genetic Algorithms, Computational..., Linear Algebra, Medical Devices, Digital Signal..., Labview
Education
California Polytechnic State University-San Luis Obispo 2009 — 2012
Master of Science, Electrical Engineering
Beijing Institute of Technology 2005 — 2009
Bachelor of Science, Communication Engineering
Masimo Corporation August 2013 - Present
Masimo Corporation August 2012 - July 2013
California Polytechnic State University, San Luis Obispo March 2010 - March 2012
St. Jude Medical CRMD January 2011 - July 2011
Dayang Technology Development Inc. July 2008 - September 2008
Skills
Electrical Engineering, Matlab, Assembly, C, VHDL, Simulink, DSP, Python, Image Processing, Simulation, Microcontrollers, Artificial Neural..., FPGA, Pattern Recognition, Servo, MIPS, Fuzzy Logic, Genetic Algorithms, Computational..., Linear Algebra, Medical Devices, Digital Signal..., Labview
Education
California Polytechnic State University-San Luis Obispo 2009 — 2012
Master of Science, Electrical Engineering
Beijing Institute of Technology 2005 — 2009
Bachelor of Science, Communication Engineering
April Pixley's St. Jude Medical-CRMD Experience 2004 - July 2008
Job Senior Director at Spinal Modulation
Industry Medical Devices
Experience
Spinal Modulation October 2013 - Present
Spinal Modulation March 2011 - October 2013
Spinal Modulation July 2008 - March 2011
St. Jude Medical CRMD 2004 - July 2008
St. Jude Medical, Inc. September 1994 - July 2008
St. Jude Medical / Ventritex, Inc. 1994 - 2008
St. Jude Medical (acquired Ventritex) 1994 - 2008
St. Jude Medical (formerly Ventritex) September 1994 - March 1998
Logica July 1992 - August 1994
General Electric June 1991 - July 1992
Skills
Firmware, Logic Analyzer, FDA, Embedded Systems, Medical Devices, Biomedical Engineering, Design Control, Product Development, Signal Processing, Software Design, Software Engineering, Debugging, Cross-functional Team..., Embedded Software, Testing, Engineering Management, Validation, Engineering, Quality System, Test Automation, Systems Engineering, CAPA, ISO 13485, Algorithms, R&D, RTOS, C, V&V, ISO 14971, ClearCase, Hardware, Microcontrollers
Education
University of Michigan 1987 — 1991
BSE, Computer Engineering
Spinal Modulation October 2013 - Present
Spinal Modulation March 2011 - October 2013
Spinal Modulation July 2008 - March 2011
St. Jude Medical CRMD 2004 - July 2008
St. Jude Medical, Inc. September 1994 - July 2008
St. Jude Medical / Ventritex, Inc. 1994 - 2008
St. Jude Medical (acquired Ventritex) 1994 - 2008
St. Jude Medical (formerly Ventritex) September 1994 - March 1998
Logica July 1992 - August 1994
General Electric June 1991 - July 1992
Skills
Firmware, Logic Analyzer, FDA, Embedded Systems, Medical Devices, Biomedical Engineering, Design Control, Product Development, Signal Processing, Software Design, Software Engineering, Debugging, Cross-functional Team..., Embedded Software, Testing, Engineering Management, Validation, Engineering, Quality System, Test Automation, Systems Engineering, CAPA, ISO 13485, Algorithms, R&D, RTOS, C, V&V, ISO 14971, ClearCase, Hardware, Microcontrollers
Education
University of Michigan 1987 — 1991
BSE, Computer Engineering
Joe Sadowski Joe Sadowski's St. Jude Medical-CRMD Experience May 1998 - October 1998
Job Owner at Mia's Place
Industry Biotechnology
Experience
Mia's Place April 2010 - Present
2010 Life Technologies October 2009 - October 2010
Amgen February 1999 - July 2009
St Jude Medical, CRMD May 1998 - October 1998
Patriot Sensors and Controls April 1989 - May 1997
Skills
Microbiology, Quality Assurance, cGMP, CAPA, Environmental Monitoring, LIMS, ISO 13485, 21 CFR Part 11, Quality Systems, SOP, Quality Auditing, GMP, Quality Control, Quality System, Sop
Education
California State University-Northridge 1991 — 1993
BS, Microbiology
California State University 1989 — 1993
BS, Microbiology
Mia's Place April 2010 - Present
2010 Life Technologies October 2009 - October 2010
Amgen February 1999 - July 2009
St Jude Medical, CRMD May 1998 - October 1998
Patriot Sensors and Controls April 1989 - May 1997
Skills
Microbiology, Quality Assurance, cGMP, CAPA, Environmental Monitoring, LIMS, ISO 13485, 21 CFR Part 11, Quality Systems, SOP, Quality Auditing, GMP, Quality Control, Quality System, Sop
Education
California State University-Northridge 1991 — 1993
BS, Microbiology
California State University 1989 — 1993
BS, Microbiology
Arya Vigeh Arya Vigeh's St. Jude Medical-CRMD Experience June 2007 - December 2007
Job Senior System Test Quality Engineer at Medtronic MiniMed
Industry Medical Devices
Experience
Medtronic June 2015 - Present
Medtronic July 2012 - June 2015
Medtronic January 2011 - July 2012
St. Jude Medical CRMD June 2007 - December 2007
Amgen Inc July 2006 - September 2006
Skills
Quality Engineering, Minitab, Medical Devices, Design Control, Validation, Software Quality..., System Testing, Biomedical Engineering, Microsoft Office, Matlab, ISO 13485, Testing, Quality Control, Embedded Systems, Black Box Testing, FDA, SAP ERP, C, Mobile Testing, IBM DOORS, Telelogic DOORS, Software Verification, MKS Integrity, Risk Analysis, RF Engineering, Unix, Fault Tree Analysis, Biomaterials, Neuroscience, Statistics, ISO 14971, 21 CFR Part 11, Physiology, Electrical Engineering, Electrophysiology, Software Requirements, System Requirements, Requirements..., VHDL, Pspice, Vi, ImageJ, MIPS, Java, Signal Processing, Use Case
Education
California Polytechnic State University-San Luis Obispo 2008 — 2011
Masters of Science, Engineering - Biomedical Engineering Specialization
California Polytechnic State University-San Luis Obispo 2003 — 2008
Bachelor of Science, Computer Engineering
Medtronic June 2015 - Present
Medtronic July 2012 - June 2015
Medtronic January 2011 - July 2012
St. Jude Medical CRMD June 2007 - December 2007
Amgen Inc July 2006 - September 2006
Skills
Quality Engineering, Minitab, Medical Devices, Design Control, Validation, Software Quality..., System Testing, Biomedical Engineering, Microsoft Office, Matlab, ISO 13485, Testing, Quality Control, Embedded Systems, Black Box Testing, FDA, SAP ERP, C, Mobile Testing, IBM DOORS, Telelogic DOORS, Software Verification, MKS Integrity, Risk Analysis, RF Engineering, Unix, Fault Tree Analysis, Biomaterials, Neuroscience, Statistics, ISO 14971, 21 CFR Part 11, Physiology, Electrical Engineering, Electrophysiology, Software Requirements, System Requirements, Requirements..., VHDL, Pspice, Vi, ImageJ, MIPS, Java, Signal Processing, Use Case
Education
California Polytechnic State University-San Luis Obispo 2008 — 2011
Masters of Science, Engineering - Biomedical Engineering Specialization
California Polytechnic State University-San Luis Obispo 2003 — 2008
Bachelor of Science, Computer Engineering
Ben Khosravi Ben Khosravi's St. Jude Medical-CRMD Experience July 2007 - August 2009
Job QA/RA, Product Development, and Manufacturing, Executive
Industry Medical Devices
Experience
St. Jude Medical January 2012 - December 2012
St. Jude Medical August 2009 - January 2012
St. Jude Medical, Cardiac Rhythm Management Division (CRMD) June 2002 - September 2009
St. Jude Medical, CRMD July 2007 - August 2009
St. Jude Medical, CRMD November 2006 - August 2009
St. Jude Medical, CRMD October 2004 - August 2009
St. Jude Medical, CRMD May 1998 - July 2007
St. jude Medical, CRMD September 2001 - October 2004
Johnson and Johnson Medical Inc., 1996 - 1998
General Electric Medical Systems 1992 - 1996
Skills
FDA, Regulatory Affairs, Program Management, Medical Devices, R&D, Quality System, Product Launch, Quality Assurance, Manufacturing, General Management, Strategic Communications, Problem Solving, Analytical Skills, Organizational..., Hands on Manager, Assertiveness, takes charge, Result Oriented, Business Strategy, Exceptionally well..., Managing Multi-Million..., Biomedical Engineering, Cross-functional Team..., CAPA, Product Development, V&V, ISO 13485, Six Sigma, Management, Continuous Improvement, Compliance, Design Control, Validation, Lean Manufacturing
Education
The Ohio State University - The Max M. Fisher College of Business 1980 — 1982
Master of Business Administration (MBA), Finance
The Ohio State University, Graduate College of Engineering 1978 — 1980
Master of Science (MS), Nuclear Engineering
the Ohio State University College of Engineering 1976 — 1978
Bachelor of Science (BS), Mechanical Engineering
St. Jude Medical January 2012 - December 2012
St. Jude Medical August 2009 - January 2012
St. Jude Medical, Cardiac Rhythm Management Division (CRMD) June 2002 - September 2009
St. Jude Medical, CRMD July 2007 - August 2009
St. Jude Medical, CRMD November 2006 - August 2009
St. Jude Medical, CRMD October 2004 - August 2009
St. Jude Medical, CRMD May 1998 - July 2007
St. jude Medical, CRMD September 2001 - October 2004
Johnson and Johnson Medical Inc., 1996 - 1998
General Electric Medical Systems 1992 - 1996
Skills
FDA, Regulatory Affairs, Program Management, Medical Devices, R&D, Quality System, Product Launch, Quality Assurance, Manufacturing, General Management, Strategic Communications, Problem Solving, Analytical Skills, Organizational..., Hands on Manager, Assertiveness, takes charge, Result Oriented, Business Strategy, Exceptionally well..., Managing Multi-Million..., Biomedical Engineering, Cross-functional Team..., CAPA, Product Development, V&V, ISO 13485, Six Sigma, Management, Continuous Improvement, Compliance, Design Control, Validation, Lean Manufacturing
Education
The Ohio State University - The Max M. Fisher College of Business 1980 — 1982
Master of Business Administration (MBA), Finance
The Ohio State University, Graduate College of Engineering 1978 — 1980
Master of Science (MS), Nuclear Engineering
the Ohio State University College of Engineering 1976 — 1978
Bachelor of Science (BS), Mechanical Engineering
Jeff Alves Jeff Alves's St. Jude Medical-CRMD Experience April 2004 - August 2011
Job Hardware Engineering Manager at Apple
Industry Consumer Electronics
Experience
Apple March 2015 - Present
Apple May 2013 - March 2015
Spinal Modulation August 2011 - May 2013
St Jude Medical CRMD April 2004 - August 2011
St. Jude Medical 2004 - March 2008
CDM Technologies January 2001 - March 2004
Skills
Debugging, Electrical Engineering, Medical Devices, Design Control, Biomedical Engineering, FDA, R&D, Design for Manufacturing, Embedded Systems, Failure Analysis, Design of Experiments, Firmware, Microcontrollers, Cross-functional Team..., Electronics, Hardware, Testing, Hardware Architecture
Education
California Polytechnic State University-San Luis Obispo 2002 — 2004
MSGE, Biomedical Engineering
California Polytechnic State University-San Luis Obispo 1998 — 2002
BSEE, Electrical Engineering
Apple March 2015 - Present
Apple May 2013 - March 2015
Spinal Modulation August 2011 - May 2013
St Jude Medical CRMD April 2004 - August 2011
St. Jude Medical 2004 - March 2008
CDM Technologies January 2001 - March 2004
Skills
Debugging, Electrical Engineering, Medical Devices, Design Control, Biomedical Engineering, FDA, R&D, Design for Manufacturing, Embedded Systems, Failure Analysis, Design of Experiments, Firmware, Microcontrollers, Cross-functional Team..., Electronics, Hardware, Testing, Hardware Architecture
Education
California Polytechnic State University-San Luis Obispo 2002 — 2004
MSGE, Biomedical Engineering
California Polytechnic State University-San Luis Obispo 1998 — 2002
BSEE, Electrical Engineering
Andrew McGarvey's St. Jude Medical-CRMD Experience August 2007 - December 2010
Job Manager, Financial Planning and Analysis at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical December 2010 - Present
St. Jude Medical - CRMD August 2007 - December 2010
Tonka Bay Equity Partners May 2007 - July 2007
Riverbridge Partners May 2006 - December 2006
St. Jude Medical June 2002 - June 2005
Education
University of Minnesota - Carlson School of Management 2005 — 2007
MBA, Finance
Washington University in St. Louis 1999 — 2002
B.S. and M.S., Mechanical Engineering
University of Puget Sound 1995 — 1999
B.S., Physics
St. Jude Medical December 2010 - Present
St. Jude Medical - CRMD August 2007 - December 2010
Tonka Bay Equity Partners May 2007 - July 2007
Riverbridge Partners May 2006 - December 2006
St. Jude Medical June 2002 - June 2005
Education
University of Minnesota - Carlson School of Management 2005 — 2007
MBA, Finance
Washington University in St. Louis 1999 — 2002
B.S. and M.S., Mechanical Engineering
University of Puget Sound 1995 — 1999
B.S., Physics
Lori Li's St. Jude Medical-CRMD Experience August 2004 - August 2014
Job Principal Systems Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical August 2014 - Present
St. Jude Medical, CRMD August 2004 - August 2014
UC Davis January 2002 - June 2002
Applied Medical Resources June 2000 - September 2000
Skills
Medical Devices, Biomedical Engineering, Systems Engineering, System Design, Project Management, Product Development, FDA, Usability Testing, System Verification, Validation, R&D, Matlab, CUA, Six Sigma, Design of Experiments, Testing, V&V, Solidworks, Biomechanics, DMAIC, Product Design, ISO 13485, FMEA, Biomaterials, Bioengineering
Education
University of California, Los Angeles 2002 — 2004
M.S., Biomedical Engineering
University of California, Davis 1998 — 2001
B.S., Biological Systems Engineering
St. Jude Medical August 2014 - Present
St. Jude Medical, CRMD August 2004 - August 2014
UC Davis January 2002 - June 2002
Applied Medical Resources June 2000 - September 2000
Skills
Medical Devices, Biomedical Engineering, Systems Engineering, System Design, Project Management, Product Development, FDA, Usability Testing, System Verification, Validation, R&D, Matlab, CUA, Six Sigma, Design of Experiments, Testing, V&V, Solidworks, Biomechanics, DMAIC, Product Design, ISO 13485, FMEA, Biomaterials, Bioengineering
Education
University of California, Los Angeles 2002 — 2004
M.S., Biomedical Engineering
University of California, Davis 1998 — 2001
B.S., Biological Systems Engineering
Emily Mirro's St. Jude Medical-CRMD Experience 1997 - 1999
Job Senior Manager, Field Clinical Engineering
Industry Biotechnology
Experience
NeuroPace September 2000 - Present
St. Jude Medical, CRMD 1997 - 1999
Skills
Medical Devices, FDA, Design Control, Biomedical Engineering, R&D, ISO 13485, ISO 14971, Biotechnology, Cross-functional Team..., V&V, Regulatory Submissions, Clinical Trials, Clinical Research, Design for Manufacturing, Start-ups, Electrophysiology, Lifesciences, Healthcare, PMA, Regulatory Affairs, Clinical Development, Validation, Quality System
Education
Butler University 1993 — 1997
B.S, Biological Sciences
NeuroPace September 2000 - Present
St. Jude Medical, CRMD 1997 - 1999
Skills
Medical Devices, FDA, Design Control, Biomedical Engineering, R&D, ISO 13485, ISO 14971, Biotechnology, Cross-functional Team..., V&V, Regulatory Submissions, Clinical Trials, Clinical Research, Design for Manufacturing, Start-ups, Electrophysiology, Lifesciences, Healthcare, PMA, Regulatory Affairs, Clinical Development, Validation, Quality System
Education
Butler University 1993 — 1997
B.S, Biological Sciences
Hilman Chung's St. Jude Medical-CRMD Experience September 2005 - August 2012
Job Principal Engineer at Boston Scientific, Interventional Cardiology
Industry Medical Devices
Experience
Boston Scientific August 2012 - Present
St Jude Medical, CRMD September 2005 - August 2012
ASE (U.S.) Inc 2002 - 2005
Skills
Design Control, ISO 14971, ISO 13485, Quality Engineering, DOE, Design of Experiments, Biomedical Engineering, Medical Devices, CAPA, Process Validation, FMEA, FDA, Supplier Quality, Quality Systems, Validation, Failure Analysis, Manufacturing..., SPC, Root Cause Analysis, Reliability, Process Development, Continuous Improvement, Quality Management, Process Improvement, Validations, Design for Manufacturing, V&V, Quality System
Education
University of California, Berkeley 1996 — 2000
Boston Scientific August 2012 - Present
St Jude Medical, CRMD September 2005 - August 2012
ASE (U.S.) Inc 2002 - 2005
Skills
Design Control, ISO 14971, ISO 13485, Quality Engineering, DOE, Design of Experiments, Biomedical Engineering, Medical Devices, CAPA, Process Validation, FMEA, FDA, Supplier Quality, Quality Systems, Validation, Failure Analysis, Manufacturing..., SPC, Root Cause Analysis, Reliability, Process Development, Continuous Improvement, Quality Management, Process Improvement, Validations, Design for Manufacturing, V&V, Quality System
Education
University of California, Berkeley 1996 — 2000
Gregg Uyeda's St. Jude Medical-CRMD Experience March 1994 - Present
Job Manager, Product AnalysisReliability at St. Jude Medical CRMD
Industry Medical Devices
Experience
St. Jude Medical CRMD March 1994 - Present
Rugged Digital Systems 1992 - 1994
Teledyne CME 1988 - 1992
Varian Associates 1985 - 1988
Education
San Jose State University
BSEE
St. Jude Medical CRMD March 1994 - Present
Rugged Digital Systems 1992 - 1994
Teledyne CME 1988 - 1992
Varian Associates 1985 - 1988
Education
San Jose State University
BSEE
Amy (Hall) Trowbridge's St. Jude Medical-CRMD Experience July 2004 - December 2004
Job Lecturer, Fulton Schools of Engineering at Arizona State University
Industry Higher Education
Experience
Arizona State University August 2010 - Present
Arizona State University January 2010 - May 2010
Arizona State University April 2009 - December 2009
Harrington Dept. of Bioengineering, Arizona State University August 2005 - December 2008
St. Jude Medical, CRMD July 2004 - December 2004
Skills
Biomedical Engineering, Bioengineering, Labview
Education
Arizona State University 2005 — 2008
MS, Bioengineering
Arizona State University 2009 — 2011
MS, Clinical Research Management
California Polytechnic State University-San Luis Obispo 2000 — 2005
BS, General Engineering: Biomedical Concentration
Arizona State University August 2010 - Present
Arizona State University January 2010 - May 2010
Arizona State University April 2009 - December 2009
Harrington Dept. of Bioengineering, Arizona State University August 2005 - December 2008
St. Jude Medical, CRMD July 2004 - December 2004
Skills
Biomedical Engineering, Bioengineering, Labview
Education
Arizona State University 2005 — 2008
MS, Bioengineering
Arizona State University 2009 — 2011
MS, Clinical Research Management
California Polytechnic State University-San Luis Obispo 2000 — 2005
BS, General Engineering: Biomedical Concentration
Nicole Polk's St. Jude Medical-CRMD Experience March 2003 - May 2013
Job HR Administrator at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical, CRMD March 2003 - May 2013
DHL Airways January 1998 - January 2002
Skills
HRIS, Onboarding
Education
College of the Canyons
AA, Liberal Studies
St. Jude Medical, CRMD March 2003 - May 2013
DHL Airways January 1998 - January 2002
Skills
HRIS, Onboarding
Education
College of the Canyons
AA, Liberal Studies
Eric Hoy's St. Jude Medical-CRMD Experience 2001 - Present
Job Manager, Advanced Process Development at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical CRMD 2001 - Present
St. Jude Medical May 2001 - May 2011
Teledyne Microelectronic Technologies 1983 - 2001
Skills
Medical Devices, Manufacturing, Six Sigma, Product Development, FDA, ISO 13485, R&D, Quality System, Lean Manufacturing
Education
University of California, Los Angeles 1976 — 1983
Masters of Science, Electrical Engineering
St. Jude Medical CRMD 2001 - Present
St. Jude Medical May 2001 - May 2011
Teledyne Microelectronic Technologies 1983 - 2001
Skills
Medical Devices, Manufacturing, Six Sigma, Product Development, FDA, ISO 13485, R&D, Quality System, Lean Manufacturing
Education
University of California, Los Angeles 1976 — 1983
Masters of Science, Electrical Engineering
Ronald Rolnick's St. Jude Medical-CRMD Experience 1997 - 2013
Job Of Counsel at Feldman Gale
Industry Medical Devices
Experience
Feldman Gale July 2013 - Present
St. Jude Medical CRMD 1997 - 2013
Sandler. Rolnick, & Morse 1979 - 1995
Skills
Intellectual Property, Patents, Regulatory Affairs, Biotechnology, FDA, Medical Devices, Licensing, Sales, Recruiting, Mergers & Acquisitions, Trade Secrets, Privacy Law, Commercialization, Cardiology, Healthcare, Biomedical Engineering
Education
University of California, Los Angeles 1972 — 1975
Doctor of Law (J.D.)
University of California, Los Angeles 1969 — 1972
Bachelor of Arts (B.A.), Psychology
Feldman Gale July 2013 - Present
St. Jude Medical CRMD 1997 - 2013
Sandler. Rolnick, & Morse 1979 - 1995
Skills
Intellectual Property, Patents, Regulatory Affairs, Biotechnology, FDA, Medical Devices, Licensing, Sales, Recruiting, Mergers & Acquisitions, Trade Secrets, Privacy Law, Commercialization, Cardiology, Healthcare, Biomedical Engineering
Education
University of California, Los Angeles 1972 — 1975
Doctor of Law (J.D.)
University of California, Los Angeles 1969 — 1972
Bachelor of Arts (B.A.), Psychology
Denise Chew's St. Jude Medical-CRMD Experience July 2008 - December 2008
Job R&D Engineer at Space Systems Loral
Industry Mechanical or Industrial Engineering
Experience
Space Systems Loral July 2012 - Present
Space Systems Loral March 2010 - July 2012
iScience Interventional December 2009 - February 2010
iScience Interventional August 2009 - December 2009
St. Jude Medical CRMD July 2008 - December 2008
Apple Inc June 2007 - September 2007
Skills
Pro/Engineer, Solidworks, Matlab, C++, Finite Element Analysis, Testing, Pro Engineer, Engineering, Manufacturing, AutoCAD, Product Development, Medical Devices, Mechanical Engineering, V&V, Labview, Design for Manufacturing, Biomedical Engineering, R&D, Engineering Management, SolidWorks, PTC Creo
Education
California Polytechnic State University-San Luis Obispo 2004 — 2009
B.S, Mechanical Engineering; Mechatronics
Space Systems Loral July 2012 - Present
Space Systems Loral March 2010 - July 2012
iScience Interventional December 2009 - February 2010
iScience Interventional August 2009 - December 2009
St. Jude Medical CRMD July 2008 - December 2008
Apple Inc June 2007 - September 2007
Skills
Pro/Engineer, Solidworks, Matlab, C++, Finite Element Analysis, Testing, Pro Engineer, Engineering, Manufacturing, AutoCAD, Product Development, Medical Devices, Mechanical Engineering, V&V, Labview, Design for Manufacturing, Biomedical Engineering, R&D, Engineering Management, SolidWorks, PTC Creo
Education
California Polytechnic State University-San Luis Obispo 2004 — 2009
B.S, Mechanical Engineering; Mechatronics
Heather Schreiber's St. Jude Medical-CRMD Experience 2006 - May 2010
Job Operations Manager at St Jude Medical
Industry Medical Devices
Experience
St. Jude Medical March 2015 - Present
St. Jude Medical January 2013 - March 2015
St. Jude Medical October 2011 - January 2013
St. Jude Medical May 2010 - October 2011
St. Jude Medical CRMD 2006 - May 2010
Skills
Design Control, ISO 13485, Product Development, Engineering, Medical Devices, FDA, V&V, CAPA, Quality System, FMEA
Education
University of Minnesota-Twin Cities 2006 — 2007
MSME, Mechanical Engineering
University of St. Thomas 2002 — 2006
Bachelors of Science, Mechanical Engineering
St. Jude Medical March 2015 - Present
St. Jude Medical January 2013 - March 2015
St. Jude Medical October 2011 - January 2013
St. Jude Medical May 2010 - October 2011
St. Jude Medical CRMD 2006 - May 2010
Skills
Design Control, ISO 13485, Product Development, Engineering, Medical Devices, FDA, V&V, CAPA, Quality System, FMEA
Education
University of Minnesota-Twin Cities 2006 — 2007
MSME, Mechanical Engineering
University of St. Thomas 2002 — 2006
Bachelors of Science, Mechanical Engineering
Yat Tam's St. Jude Medical-CRMD Experience January 2004 - July 2004
Job Applications Engineer Power Management
Industry Semiconductors
Experience
Dialog Semiconductor April 2013 - Present
Linear Technology June 2005 - March 2013
St. Jude Medical CRMD January 2004 - July 2004
Alcon Laboratories Inc. June 2002 - December 2002
Skills
PCB design, Analog, IC, Failure Analysis, Power Supply Design, Electrical Engineering, Power Electronics, Test Automation, Power Supplies, Semiconductors, Product Evaluation, Prototype, Embedded Systems
Education
California Polytechnic State University-San Luis Obispo 2000 — 2005
BS & MS
Cosumnes River College 1997 — 2000
AA
Laguna Creek High School 1994 — 1997
St. Paul Convent School 1991 — 1994
Dialog Semiconductor April 2013 - Present
Linear Technology June 2005 - March 2013
St. Jude Medical CRMD January 2004 - July 2004
Alcon Laboratories Inc. June 2002 - December 2002
Skills
PCB design, Analog, IC, Failure Analysis, Power Supply Design, Electrical Engineering, Power Electronics, Test Automation, Power Supplies, Semiconductors, Product Evaluation, Prototype, Embedded Systems
Education
California Polytechnic State University-San Luis Obispo 2000 — 2005
BS & MS
Cosumnes River College 1997 — 2000
AA
Laguna Creek High School 1994 — 1997
St. Paul Convent School 1991 — 1994
Sharathchandra Somayaji's St. Jude Medical-CRMD Experience August 2006 - May 2009
Job Sr NPI Manager, Instruments at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical August 2015 - Present
Intuitive Surgical August 2012 - Present
Intuitive Surgical August 2010 - Present
St. Jude Medical - CRMD August 2006 - May 2009
Applied Materials August 2004 - August 2006
Stanford University September 2003 - June 2004
Stanford University January 2003 - September 2003
Skills
Manufacturing, Design of Experiments, Medical Devices, Leadership, Product Development, Cross-functional Team..., Project Management, Product Design, Design Control, Engineering, Management, R&D, Design for Manufacturing, FMEA, ISO 13485
Education
Stanford University
M.S, Mechanical Engineering
Intuitive Surgical August 2015 - Present
Intuitive Surgical August 2012 - Present
Intuitive Surgical August 2010 - Present
St. Jude Medical - CRMD August 2006 - May 2009
Applied Materials August 2004 - August 2006
Stanford University September 2003 - June 2004
Stanford University January 2003 - September 2003
Skills
Manufacturing, Design of Experiments, Medical Devices, Leadership, Product Development, Cross-functional Team..., Project Management, Product Design, Design Control, Engineering, Management, R&D, Design for Manufacturing, FMEA, ISO 13485
Education
Stanford University
M.S, Mechanical Engineering
Gabriel Mouchawar's St. Jude Medical-CRMD Experience 1992 - Present
Job Vice President, Electrical Engineering at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical April 2015 - Present
St. Jude Medical July 2011 - Present
St. Jude Medical November 2009 - Present
St. Jude Medical CRMD 1992 - Present
Skills
Medical Devices, Design Control, Biomedical Engineering, Product Development, Clinical Trials, FDA, ISO 13485, ISO 14971, V&V, R&D, Engineering, Validation, Clinical Development, Cross-functional Team..., Quality System, Product Launch, CAPA, Hardware Diagnostics, Commercialization, Design for Manufacturing, Design of Experiments, FMEA, GMP, Biotechnology
Education
Purdue University 1986 — 1991
PhD, Electrical & Biomedical Engineering
St. Jude Medical April 2015 - Present
St. Jude Medical July 2011 - Present
St. Jude Medical November 2009 - Present
St. Jude Medical CRMD 1992 - Present
Skills
Medical Devices, Design Control, Biomedical Engineering, Product Development, Clinical Trials, FDA, ISO 13485, ISO 14971, V&V, R&D, Engineering, Validation, Clinical Development, Cross-functional Team..., Quality System, Product Launch, CAPA, Hardware Diagnostics, Commercialization, Design for Manufacturing, Design of Experiments, FMEA, GMP, Biotechnology
Education
Purdue University 1986 — 1991
PhD, Electrical & Biomedical Engineering
Barathi Sethuraman's St. Jude Medical-CRMD Experience 2000 - 2008
Job Vice President, Clinical Science at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical March 2015 - Present
Coherex Medical March 2014 - February 2015
Abbott Vascular Structural Heart October 2009 - February 2014
Evalve, Inc. November 2008 - October 2009
St. Jude Medical - CRMD 2000 - 2008
LifeScan 1998 - 2000
Skills
People Management, Organizational..., Process Development, Process Management, Medical Devices, Data Management, Statistics, Clinical Study Design, FDA, Clinical Trials, Clinical Research, Biomedical Engineering, Clinical Development, Biostatistics, PMA, EDC, GCP, Biotechnology, CTMS, Cardiology, Data Analysis, IDE
Education
University of California, Berkeley 1991 — 1997
Ph.D, Statistics
Indian Institute of Technology, Kanpur 1985 — 1990
Master of Science, Statistics
St. Jude Medical March 2015 - Present
Coherex Medical March 2014 - February 2015
Abbott Vascular Structural Heart October 2009 - February 2014
Evalve, Inc. November 2008 - October 2009
St. Jude Medical - CRMD 2000 - 2008
LifeScan 1998 - 2000
Skills
People Management, Organizational..., Process Development, Process Management, Medical Devices, Data Management, Statistics, Clinical Study Design, FDA, Clinical Trials, Clinical Research, Biomedical Engineering, Clinical Development, Biostatistics, PMA, EDC, GCP, Biotechnology, CTMS, Cardiology, Data Analysis, IDE
Education
University of California, Berkeley 1991 — 1997
Ph.D, Statistics
Indian Institute of Technology, Kanpur 1985 — 1990
Master of Science, Statistics
Christopher Kuykendall's St. Jude Medical-CRMD Experience January 2000 - April 2009
Job Direct Ship/Receiving Warehouse Lead at Sun Products Corporation
Industry Civic & Social Organization
Experience
Sun Products Corporation May 2012 - Present
Bacchus Rentals April 2009 - May 2012
St. Jude Medical CRMD January 2000 - April 2009
Skills
Analysis, Business Analysis, Laptops, HTML, Lean Manufacturing, Visual Studio, Visio, Teamwork, Microsoft Office, Computer Hardware, XP, Medical Devices, Software Installation, Project Planning, Customer Service, Shipping, MS Project, Integration, Technical Writing, Servers, Testing, Software Documentation, SharePoint, Troubleshooting, Logistics, Process Improvement, Warehousing, Access, CRM, System Administration, Six Sigma, Vendor Management, Windows, Quality Assurance, Project Management, Team Leadership, Supervisory Skills, Leadership, SAP, Cross-functional Team..., ERP, Inventory Management, Operations Management, Training, Program Management, Materials Management, Manufacturing
Education
DeVry University 1999 — 2003
Bachelors of Science, Computer Information Systems
Sun Products Corporation May 2012 - Present
Bacchus Rentals April 2009 - May 2012
St. Jude Medical CRMD January 2000 - April 2009
Skills
Analysis, Business Analysis, Laptops, HTML, Lean Manufacturing, Visual Studio, Visio, Teamwork, Microsoft Office, Computer Hardware, XP, Medical Devices, Software Installation, Project Planning, Customer Service, Shipping, MS Project, Integration, Technical Writing, Servers, Testing, Software Documentation, SharePoint, Troubleshooting, Logistics, Process Improvement, Warehousing, Access, CRM, System Administration, Six Sigma, Vendor Management, Windows, Quality Assurance, Project Management, Team Leadership, Supervisory Skills, Leadership, SAP, Cross-functional Team..., ERP, Inventory Management, Operations Management, Training, Program Management, Materials Management, Manufacturing
Education
DeVry University 1999 — 2003
Bachelors of Science, Computer Information Systems
Joyce Babayan's St. Jude Medical-CRMD Experience November 2009 - Present
Job Manager, Clinical Affairs, Contracting Services at St Jude Medical, CRMD
Industry Medical Devices
Experience
St Jude Medical, CRMD November 2009 - Present
St Jude Medical, CRMD January 2002 - Present
Skills
Cardiology, Medical Devices, FDA, Clinical Trials, Biomedical Engineering, Electrophysiology, Clinical Research, Cross-functional Team..., Clinical Study Design
Education
California State University-Northridge
BA, Biology
St Jude Medical, CRMD November 2009 - Present
St Jude Medical, CRMD January 2002 - Present
Skills
Cardiology, Medical Devices, FDA, Clinical Trials, Biomedical Engineering, Electrophysiology, Clinical Research, Cross-functional Team..., Clinical Study Design
Education
California State University-Northridge
BA, Biology
Cory Sullivan's St. Jude Medical-CRMD Experience 2009 - 2010
Job Quality Engineer at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences 2010 - Present
St. Jude Medical, CRMD 2009 - 2010
Thoratec Corporation 2006 - 2009
Skills
Design Control, ISO 13485, ISO 14971, Design of Experiments, Medical Devices, Biomedical Engineering, CAPA, V&V, FDA, Quality System, SPC, Minitab, FMEA, CE marking, R&D, Validation, Root Cause Analysis, Supplier Quality, CQE, Catheters
Education
Northeastern University
MS Mechanical Engineering, Material Science
Worcester Polytechnic Institute
BS Mechanical Engineering
Edwards Lifesciences 2010 - Present
St. Jude Medical, CRMD 2009 - 2010
Thoratec Corporation 2006 - 2009
Skills
Design Control, ISO 13485, ISO 14971, Design of Experiments, Medical Devices, Biomedical Engineering, CAPA, V&V, FDA, Quality System, SPC, Minitab, FMEA, CE marking, R&D, Validation, Root Cause Analysis, Supplier Quality, CQE, Catheters
Education
Northeastern University
MS Mechanical Engineering, Material Science
Worcester Polytechnic Institute
BS Mechanical Engineering
Jimmy Grape's St. Jude Medical-CRMD Experience October 2010 - April 2013
Job RN, BS, CCRP, Clinical Research Associate, Cardiac Cath Lab Manager
Industry Medical Devices
Experience
Dignity Health / Glendale Memorial Hospital November 2014 - Present
St. Jude Medical April 2013 - October 2014
St. Jude Medical, CRMD October 2010 - April 2013
Glendale Memorial Hospital November 2006 - October 2010
Glendale Memorial Hospital and Health Center February 2000 - November 2006
Cedars-Sinai Medical Center October 1998 - November 1999
Hollywood Community Hospital February 1990 - October 1997
Skills
Clinical Trials, Clinical Research, Medical Devices, Cardiology, FDA, Management, Electrophysiology, EDC, Healthcare, Critical Care Nursing, Hemodynamic Monitoring, GCP, Regulatory Guidelines, Protocol, Oncology, Clinical Development, Biomedical Engineering, Biotechnology, Hospitals, CTMS, ICU, Training, Medicine
Education
University of La Verne 2013 — 2015
MBA, Leadership & Management
University of La Verne 2010 — 2012
Bachelor of Science (BS), Organizational Management, 4.0
St. Vincents Hospital 1997 — 1998
Critical Care Nursing
Los Angeles City College (LACC) 1981 — 1984
ADN (Assoc. Degree Nursing), Registered Nursing/Registered Nurse
Cleveland High School 1975 — 1977
High School Diploma
Dignity Health / Glendale Memorial Hospital November 2014 - Present
St. Jude Medical April 2013 - October 2014
St. Jude Medical, CRMD October 2010 - April 2013
Glendale Memorial Hospital November 2006 - October 2010
Glendale Memorial Hospital and Health Center February 2000 - November 2006
Cedars-Sinai Medical Center October 1998 - November 1999
Hollywood Community Hospital February 1990 - October 1997
Skills
Clinical Trials, Clinical Research, Medical Devices, Cardiology, FDA, Management, Electrophysiology, EDC, Healthcare, Critical Care Nursing, Hemodynamic Monitoring, GCP, Regulatory Guidelines, Protocol, Oncology, Clinical Development, Biomedical Engineering, Biotechnology, Hospitals, CTMS, ICU, Training, Medicine
Education
University of La Verne 2013 — 2015
MBA, Leadership & Management
University of La Verne 2010 — 2012
Bachelor of Science (BS), Organizational Management, 4.0
St. Vincents Hospital 1997 — 1998
Critical Care Nursing
Los Angeles City College (LACC) 1981 — 1984
ADN (Assoc. Degree Nursing), Registered Nursing/Registered Nurse
Cleveland High School 1975 — 1977
High School Diploma
Otto Chiu's St. Jude Medical-CRMD Experience September 2005 - April 2009
Job Senior Software Engineer at Tesla Motors
Industry Computer Software
Experience
Tesla Motors March 2012 - Present
St. Jude Medical - AFD April 2009 - March 2012
St. Jude Medical - CRMD September 2005 - April 2009
CyberSource June 2004 - January 2005
Embark Corp. June 2003 - August 2003
Skills
C, Embedded Systems, Java, Python, Software Development, Object Oriented Design, XML, Firmware, HTML, C, Software Engineering, Perl, Android, Scrum, Linux, Agile Methodologies, C++, Embedded Software, RTOS, Medical Devices, Unix, UML, Distributed Systems, Software Design
Education
Cal State Fullerton 2010 — 2012
MS, Software Engineering
UC Berkeley 2001 — 2005
BA, Computer Science
Tesla Motors March 2012 - Present
St. Jude Medical - AFD April 2009 - March 2012
St. Jude Medical - CRMD September 2005 - April 2009
CyberSource June 2004 - January 2005
Embark Corp. June 2003 - August 2003
Skills
C, Embedded Systems, Java, Python, Software Development, Object Oriented Design, XML, Firmware, HTML, C, Software Engineering, Perl, Android, Scrum, Linux, Agile Methodologies, C++, Embedded Software, RTOS, Medical Devices, Unix, UML, Distributed Systems, Software Design
Education
Cal State Fullerton 2010 — 2012
MS, Software Engineering
UC Berkeley 2001 — 2005
BA, Computer Science
Beena Flynn's St. Jude Medical-CRMD Experience 2003 - 2012
Job Assistant Director, Regulatory Affairs at Alcon Laboratories, Inc.
Industry Medical Devices
Experience
Alcon Laboratories, Inc. July 2012 - Present
St. Jude Medical, CRMD 2003 - 2012
Advanced Bionics 2001 - 2003
St. Jude Medical, CRMD 1997 - 2001
Skills
IDE Protoocol..., IDE Site Training, Conduct IDE Studies, IDE Site Monitoring, PMA Application, PMA Supplement..., PMA Post Approval..., PMA and IDE Annual..., 510(k) Application, Pre-DE Applications, Project Management, Sustaining Activities, FDA
Education
Arizona State University
Bioengineering
Osmania University
Business
Alcon Laboratories, Inc. July 2012 - Present
St. Jude Medical, CRMD 2003 - 2012
Advanced Bionics 2001 - 2003
St. Jude Medical, CRMD 1997 - 2001
Skills
IDE Protoocol..., IDE Site Training, Conduct IDE Studies, IDE Site Monitoring, PMA Application, PMA Supplement..., PMA Post Approval..., PMA and IDE Annual..., 510(k) Application, Pre-DE Applications, Project Management, Sustaining Activities, FDA
Education
Arizona State University
Bioengineering
Osmania University
Business