Cardima Company
Industry: Company
DescriptionHeadquarters: Fremont, CA Founded: 1992
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Cardima Employees
LAAx, Inc. 2006 - Present
Born of Sound 2012 - Present
BaroSense, Inc. 2005 - 2006
Cardima 2003 - 2005
Skills
Medical Devices, Biomedical Engineering, Engineering, ISO 13485, Biomedical Devices, Design Control, Quality System, FDA, Design for Manufacturing, Machining, R&D, Cross-functional Team..., CAPA, Product Development, Validation, V&V, SolidWorks, Design of Experiments, Manufacturing, Commercialization, Biotechnology, Product Design
Education
Northwestern University 2001 — 2002
Master's degree, Bioengineering and Biomedical Engineering
The Johns Hopkins University 1997 — 2001
Bachelor's degree, Bioengineering and Biomedical Engineering
Abbott Vascular October 2014 - Present
Abbott Vascular March 2011 - Present
Abbott Vascular December 2007 - June 2011
Abbott Vascular March 2005 - September 2007
Guidant October 2001 - March 2005
Guidant July 1999 - October 2001
Cardima June 1996 - July 1999
Sumitomo Sitix Silicon September 1994 - June 1996
Skills
Medical Devices, Quality Systems, Quality Engineering, Regulatory Affairs, Regulatory Compliance, Quality System, Design Control, Change Control, Quality Auditing, Compliance, Quality Control, Quality Management, Validation, FDA, ISO 13485, CAPA
Education
San Jose State University 1989 — 1994
BS
KLA-Tencor February 2011 - Present
Magley & Associates June 2010 - January 2011
Blue Coat Systems May 2005 - January 2010
Cardima September 2001 - April 2005
Breakaway Solutions August 2000 - April 2001
IOS Workspace Installations May 1996 - August 2000
Bank of America 1992 - 1996
Skills
Structures, Onboarding, HRIS, Talent Acquisition, Vendor Management, Process Improvement, HR Policies, New Hire Orientations, Employee Benefits, Benefits Administration, Strategic Planning, Project Management, Benchmarking, Benefits Design, Qualified Retirement..., Disability Management, Leave of Absence..., Internal Communications, Global Operations, Acquisitions, Total Rewards, Deferred Compensation, Compensation & Benefit, ADP Payroll, Program Management, SaaS, Compensation & Benefits
Education
San Jose State University 1994 — 1996
BS, Human Resource Management
Apple February 2013 - Present
Linear Technology June 2010 - January 2013
Cardima January 2010 - June 2010
San Jose State University August 2009 - June 2010
Alcatel-Lucent May 2007 - August 2007
Alcatel-Lucent May 2006 - August 2006
Skills
Analog Circuit Design, Failure Analysis, Debugging, bench testing, Manual Testing, SEM, FIB, Cadence Virtuoso, EDX, mechanical etching, Wet Chemical Etching, Liquid Crystals, photo emission analysis, Analog, ASIC, CMOS, Cadence, Electrical Engineering, IC, Mixed Signal, PLL, RF, Test Engineering, Test Processes, Verilog
Education
San Jose State University 2008 — 2010
MSEE, Electrical Engineering
Jaypee University of Information Technology 2004 — 2008
B.Tech, Electronics and Communication Engineering
Don bosco 1991 — 2004
Arista Networks, Inc. September 2012 - Present
IntApp, Inc. June 2012 - September 2012
Codman Neurovascular (a J&J company – acquired Micrus on 9/27/2010)/Micrus Endovascular October 2008 - April 2012
TIBCO Software 2007 - 2008
Cardima 2005 - 2007
Aspect Software 1995 - 2005
Skills
Payroll, ADP Payroll, Accounts Receivable, Accounting, Process Improvement, Account Reconciliation, Budgets, Financial Reporting, Auditing, Employee Benefits, Bank Reconciliation, Customer Service, Journal Entries, Management, Accruals, Human Resources, Internal Audit, Internal Controls, Sarbanes-Oxley Act, SAP, Software Documentation
Education
Mission College, Santa Clara, CA
Accounting Units
Adamson University 1982 — 1987
Bachelors Degree, Industrial Engineering
SI-BONE, Inc. January 2012 - Present
Wild Iris Consulting LLC January 2004 - Present
HourGlass Technologies Inc. July 2011 - July 2012
Chestnut Medical Technologies May 2008 - March 2012
Pulmonx March 2007 - January 2008
Kyphon September 2006 - March 2007
Cardima October 2003 - September 2004
Conceptus 1998 - 2000
Skills
Medical Devices, FDA, Regulatory Affairs, Clinical Trials, Clinical Research, Start-ups, Orthopedic, ISO 13485, CAPA, Quality System, R&D, Regulatory Submissions, Biotechnology, Lifesciences, Design Control, CE marking, Spine, Product Development, Interventional..., Statistics, Bayesian statistics, Web Applications, Electronic Data..., Report Writing
Education
Yale University School of Medicine 1986 — 1990
Doctor of Medicine (M.D.), 1990
Stanford University 1982 — 1986
BS, Biology
Invuity Inc August 2010 - August 2011
Evalve, Inc. August 2004 - November 2009
Baxter Healthcare/ Fusion Medical November 1999 - August 2004
Sulzer Vascutek April 1999 - November 1999
Cardima July 1997 - April 1999
Advanced Cardiovascular Systems/ Guidant September 1994 - July 1997
Intervascular,Inc January 1987 - September 1994
Skills
Medical Devices, Product Launch, Cardiology, Vascular, Capital Equipment, Market Development, Interventional..., Surgeons, Operating Room, Disposables, Orthopedic, Cath Lab, Cardiac Surgery, Spine, ENT, Clinical Research
Education
The University of Memphis
BA, Marketing
Webb School
Penumbra,Inc. January 2011 - Present
Cardima April 2006 - October 2010
Education
Ohlone College
NVIDIA September 2012 - Present
Intematix June 2011 - August 2012
Kellogg Company November 2009 - November 2010
Cardima June 2009 - August 2009
Precision Castparts May 2008 - August 2008
North Marin Water District November 2006 - January 2007
Skills
SolidWorks, Pro/Engineer, AutoCAD, Inventor, Matlab, COMSOL, Autodesk Simulation CFD, ANSYS, Solidworks, Pro Engineer, Six Sigma, CFD, CAD, Labview, Lean Manufacturing, Finite Element Analysis, Catia, Design of Experiments, Mechanical Engineering, Testing, Manufacturing, Heat Transfer, Engineering, Machining, Thermodynamics, Thermal, SPC, Injection Molding, Materials, Design for Manufacturing, Electronics, R&D, Simulations
Education
San Jose State University
MSME, Mechanical Engineering
San Jose State University
B.S, Mechanical Engineering
San Marin High School
Woll Bio Orthopedics LLC June 2005 - Present
QuantumCor, Inc. June 2007 - September 2012
LoneStar Heart, Woll Bio, Pacific Surgical 2009 - 2010
Cardima 1993 - 1998
Skills
Intellectual Property;...
Education
University of Nebraska-Lincoln
Mechanical Engineering, Engineering
Hunter Technology 2014 - Present
Solta 2011 - 2013
Cardima 2009 - 2011
Cerus 2006 - 2009
Novartis 2000 - 2006
Cardiovention 1998 - 2000
Sanofi / Gencell 1997 - 1998
Guidant 1991 - 1997
Skills
Cross-functional Team..., Lifesciences, CAPA, R&D, ISO 13485, Clinical Development, Project Management, GMP, Biotechnology, Medical Devices, FDA, Leadership, Product Development, Budgets, Clinical Trials, Quality System, Design Control, Product Launch, Pharmaceutical Industry, Start-ups, Marketing, V&V, ISO, ISO 14971, Lean Manufacturing, Validation, Engineering
Education
Santa Clara University - Leavey School of Business
MBA, Technology Innovation
Oregon State University
BS, Engineering ME/IE
Bloom Energy January 2014 - Present
Sr. Equity Manager / Stock Plan Consultant July 2013 - Present
Independent Consultant January 2011 - Present
SOA Projects Inc. June 2012 - June 2013
NeoPhotonics Corporation January 2011 - June 2011
CARDIMA October 2008 - December 2010
Aradigm March 2005 - October 2008
Lipid Sciences 2002 - 2005
Cardima, Inc. May 1998 - February 2002
TTI, Inc. August 1997 - April 1998
Skills
SEC reporting, SOX, Financial Reporting, Tax, Budgeting, CEP - Global stock plan..., Project Implementation, Business Systems..., Section 16 reporting, Payroll (domestic &..., Cash Management, Collections, Revenue Recognition, Sarbanes-Oxley Act, Compliance, Internal Controls, Budgets, Solution Implementation, Accounts Receivable, Accounts Payable, Auditing, Consolidation, Accounting, SEC filings, Account Reconciliation, Sarbanes-Oxley, GAAP, Finance, Payroll, Fixed Assets, ADP Payroll, Financial Statements, CPA, Forecasting, Financial Modeling, Internal Audit, Financial Analysis, US GAAP, Cost Accounting, Journal Entries, IFRS, SEC Filings
Education
San Jose State University 1993 — 1996
BS
Santa Clara University
CEP
Retired January 2014 - Present
TriReme Medical February 2012 - January 2014
Steven David Gallery March 2011 - January 2013
Cardima October 2009 - September 2010
ESTECH May 2005 - June 2009
ESTECH Cardiac Surgery Specialists 2005 - 2009
Amdahl Corp / TrustedAnswer.com February 2000 - September 2001
Pragmatech Software October 1997 - November 1999
Skills
Capital Equipment, Medical Devices, Cross-functional Team..., Cardiology, Disposables, Operating Room, Surgery, Cardiac Surgery, Interventional..., FDA, Product Marketing, Market Development, ISO 13485, Orthopedic, Healthcare, Sales Operations, Marketing, Interventional Radiology, Surgeons, Hospitals, Quality System, Product Launch, Clinical Research, Product Development, Cath Lab, Sales Management, Management, Selling, Product Management, Sales, Forecasting, Global Marketing, Vascular, Sales Effectiveness, Commercialization, Business Development, Customer Service, Competitive Analysis, Start-ups, Surgical Instruments
Education
Portland State University 1990 — 1992
Master, Business
California State University-Fullerton 1987 — 1989
Business, Marketing
Chaffey 1976 — 1980
High School Diploma, College Prep
Applied Materials February 2014 - Present
Space Systems Loral July 2010 - February 2014
Cardima October 2008 - July 2010
Applied Materials, Inc. February 2006 - February 2008
Microsoft Corporation September 2005 - February 2006
Superior Technical Resources May 2004 - September 2005
Kelly Engineering Resources 2002 - 2004
NetRatings Inc February 2001 - June 2001
Applied Materials March 2000 - January 2001
West Valley Staffing Group March 1997 - March 2000
Skills
Applicant Tracking..., Technical Recruiting, Talent Acquisition, Internet Recruiting, Temporary Staffing, College Recruiting, Recruiting, Human Resources, Benefits Negotiation, Sourcing, Talent Management, Workforce Planning, Onboarding, Contract Recruitment, Screening, Interviews, Management, Temporary Placement, Cross-functional Team..., Networking, Employee Engagement, Job Descriptions, Process Improvement, Deferred Compensation, New Hire Orientations, Screening Resumes, HRIS, Cold Calling, Personnel Management, Hiring, Staffing Services, Program Management, Search, Employee Relations, Job Fairs, Training, Benefits Administration, Staff Augmentation, PeopleSoft, Taleo
Education
San Jose State University
BS, Human Resources Management
Micrel July 2004 - Present
IntelliCorp August 1999 - July 2004
Cardima July 1997 - August 1999
KLA-Tencor October 1991 - July 1997
Electroglas January 1984 - October 1991
Skills
Internal Audit, Internal Controls, Internal Investigations, Budget Management, SEC Financial Reporting, Variance Analysis, Process Improvement, Project Management, Financial Analysis, Financial Reporting, SOX 404, Corporate Governance, Corporate Finance, Consolidated Reporting, Cost Accounting, Auditing, Sarbanes-Oxley Act
Education
Golden Gate University
Accounting and Finance
UC Davis Medical Center September 2010 - Present
Association of Physician Assistans in Cardiovascular Surgery January 2008 - November 2014
Cardima December 2008 - September 2010
Stamford Hospital - Stamford Connecticut November 2007 - December 2008
Enloe Medical Center - Chico, CA April 2005 - November 2007
Good Samaritan Regional Medical Center - Corvallis Oregon December 2003 - April 2005
Kaweah Delta District Hospital - Visalia, CA July 1998 - December 2003
Salinas Urgent Care - Salinas, CA January 1997 - July 1998
Salinas Valley Memorial Hospital - Salinas, CA January 1997 - July 1998
Natividad Medical Center - Salinas, CA January 1997 - April 1997
Skills
Surgery, Healthcare, Heart Failure, Cardiac Surgery, Hospitals, Cardiothoracic Surgery, Clinical Research, Vascular Surgery, Vascular, Critical Care, Cardiac, Clinical Trials, ICU, Inpatient, Nursing, Medicine, Pediatrics, Medical Devices, Cardiology, EMR, Medical Education, Thoracic, Emergency Room, FDA, Internal Medicine, ACLS, Healthcare Consulting, EHR, Patient Safety
Education
University of Nebraska Medical Center 2005 — 2007
MPAS, Cardiothoracic and Vascular Surgery
Excelsior College 1997 — 2003
BS, Computer Sciences
Stanford University School of Medicine 1995 — 1997
PA, Physician Assistant
Hartnell College, Salinas CA 1989 — 1993
AS, Liberal Sciences
Trailblazer Design LLC September 2001 - Present
EOO, Inc. 2001 - 2007
Symphonix Devices, Inc. October 1998 - October 2001
Cardima 1994 - 1998
ADAC Laboratories 1982 - 1991
Skills
Medical Devices, Start-ups, Medical Imaging, Engineering, FDA, Product Development, R&D, Cross-functional Team..., Electronics, System Design, Manufacturing, Algorithms, Matlab, Validation, Patents, Embedded Systems, Testing, Sensors, Product Launch, Biomedical Engineering, Electrical Engineering, Management, Biotechnology, Quality System, Product Management, Market Development, Firmware, Systems Engineering, Aerospace, Product Design, FMEA, Engineering Management, Wireless, Embedded Software, Digital Signal..., Hardware Architecture, Analog, LabVIEW, Project Management, Mobile Devices, Semiconductors, Analog Circuit Design
Education
University of California, Berkeley 1973 — 1982
BSEE, Bioengineering, Electrical Engineering and Computer Science, GPA 3.85 of 4.0
University of California, Berkeley 1964 — 1969
Bachelor of Science (B.Sc.), Electronic Engineering and Computer Science and Bioengineering
Canon Business Process Services, Inc. April 2013 - Present
Otsuka America Pharmaceutical, Inc. May 2008 - April 2013
PDL BioPharma July 2005 - May 2008
Cardima September 2000 - June 2005
Public Health Institute April 1999 - September 2000
Nutrablast Nutraceuticals March 1998 - November 1999
Skills
Marketing, Budgets, Medical Devices, Biotechnology, Administrative...
Education
University of Phoenix 2008 — 2012
BSBM, Marketing
Community Hospital at the Monterey Peninsula January 2008 - Present
State Farm Insurance July 2004 - December 2007
St. Jude Medical July 2001 - July 2004
Cardima July 1998 - July 2001
Johnson & Johnson January 1993 - July 1998
Medtronic April 1992 - January 1993
Eli Lilly and Company August 1988 - April 1992
Skills
Strategic Planning, Team Building, Leadership Development, Public Speaking, Customer Service, Cross-functional Team..., Coaching, Recruiting, Organizational...
Education
Golden Gate University 1994 — 1997
MBA, Finance
San Diego State University-California State University
B.S., International Marketing
Abbott Vascular Senior R&D Extrusion TechnicianABBOTT VASCULAR2006 - Present
Cardima September 1997 - November 2005
GUIDANT CORPORATION ( ACS, PSG & DVI ) 1987 - 1997
Skills
Polymers Procedures, Mechanical Drawings, Development of medical..., Product Development, Medical Devices, Problem Solving, Design Control, Process Improvement, Solidworks, Quality System, Design of Experiments, R&D, FMEA, Lean Manufacturing, Quality Assurance, Continuous Improvement, Manufacturing, Process Engineering, Design Drafting..., Product Design, Quality Management, Validation
Education
De Anza College
Mission College
Mechanical Drawing
Universidad de San Andres
Autonomic Technologies July 2013 - March 2014
CR Bard (FlowCardia Technology Center) September 2011 - July 2013
CR Bard (FlowCardia Technology Center) August 2010 - September 2011
Cardima January 2009 - August 2010
Circle Medical Devices December 2007 - January 2009
Circle Medical Devices May 2006 - December 2007
Ciphergen January 2004 - May 2006
Gravity Probe B June 1999 - January 2004
Skills
FDA, Quality System, ISO 13485, Design Control, Medical Devices, GMP, Testing, Manufacturing..., Quality Control, Continuous Improvement, Design of Experiments, V&V, FMEA, ISO, CAPA, Quality Assurance, Calibration, Catheters, Machining, Root Cause Analysis, Biomedical Engineering, Sterilization, SPC, Quality Management, ISO 14971, Supplier Quality, 21 CFR Part 11, Sop, Change Control, SOP
Education
Stanford University 1995 — 1999
BS
St. Paul's School 1991 — 1995
Genentech February 2014 - Present
Global Project Partners, LLC July 2013 - Present
Integrated Project Management June 2011 - July 2013
Thoratec August 2010 - June 2011
Cardima April 2009 - August 2010
Cardima March 2008 - April 2009
Boston Scientific January 2007 - March 2008
Boston Scientific June 2006 - September 2006
Smuckers / Sabroso Co March 2005 - August 2005
Skills
GMP, Design Control, Medical Devices, Industrial Engineering, FDA
Education
California Polytechnic State University-San Luis Obispo 2000 — 2006
Bachelor of Science
TE Connectivity December 2003 - Present
Cardima September 2000 - November 2003
CryoCath Technologies 2001 - 2003
Skills
Medical Devices, Patents, Product Development, Product Launch, Electronics, R&D, Engineering, Manufacturing..., Cross-functional Team..., ISO 13485, Design for Manufacturing, FDA, Six Sigma, Engineering Management, Pro Engineer, Product Management, Quality System, Validation, Product Marketing, Electrical Engineering, Design of Experiments, FMEA, Lean Manufacturing, Continuous Improvement, Biomedical Engineering, Solidworks, Start-ups, PCB design, Manufacturing, Value Stream Mapping, Kaizen, Process Engineering, 5S, Electricians, Process Simulation, Materials, Testing, Injection Molding, Test Equipment, GD&T, Tolerance Analysis, Automation
Education
Sorbonne University 1980 — 1984
French literature, Electro mechanics
Esteqlal 1960 — 1972
Bachelor of Science (BS), Communication and Media Studies
Global Project Partners, LLC May 2014 - Present
Self Employed-Consultant March 2012 - May 2014
Abbott Vascular September 2010 - March 2012
Cardima January 2008 - September 2010
ABBOTT VASCULAR / GUIDANT CORP March 2005 - January 2008
Skills
Program Management, Quality System, Design Control, R&D, ISO 14971, FMEA, Manufacturing, Machining, Strategy, V&V, Biomedical Engineering, ISO, Minitab, Medical Devices, ISO 13485, Design of Experiments, Validation, Root Cause Analysis, Quality Assurance, FDA, Process Engineering, Lean Manufacturing, Cross-functional Team..., GMP, Engineering, CAPA, SPC, Six Sigma, Regulatory Affairs
Education
Drexel University 1998 — 2003
B.S, Biomedical Engineering
University of California
M.S, Chemical Engineering
Abbott EP June 2014 - Present
Hayek Medical Devices June 2013 - June 2014
Business & Health Care Consultants September 2010 - June 2013
CryoCath Technologies/Medtronic LLP, AF Solutions February 2004 - September 2010
Medtronic Sofamor Danek April 2003 - February 2004
Cardima January 2001 - April 2003
Apple Medical February 1999 - January 2001
Yale New Haven Hospital June 1987 - 1998
Skills
Negotiation, Forecasting, Budgeting, Contract Management, Cardiology, Clinical, Capital Equipment, Electrophysiology, Medical Devices, Sales Management, Product Development, New Business Development, Strategic Planning, Consultative Selling, Customer Relations, Product Management, Marketing Strategy, Account Management, Healthcare, Microsoft Office, Start-ups, Business Planning, Problem Solving, Customer Service, Contract Negotiation, Team Building, Surgery, Cardiac, Direct Sales, Business Strategy, PowerPoint, Market Analysis, Market Research, Cross-functional Team..., Solution Selling, Market Planning, Fundraising, Word, Product Marketing, Sales Support, Excel, Strategy Development, Product Launch, Coaching, Competitive Analysis, Public Speaking, Selling, Budgets, Strategy, Sales Operations
Education
Quinnipiac University
BS, Respiratory Therapist
Stanford Hospital and Clinics August 2011 - Present
Hill-Rom March 2010 - August 2011
Stanford University Medical Center March 2010 - August 2011
Hansen Medical March 2008 - March 2010
Marin General Hospital September 2004 - March 2008
Broncus Technologies September 2003 - September 2004
Cardima 1996 - 2003
St. Jude Medical November 1994 - November 1996
St. Joseph Hospital 1985 - November 1994
St. Joseph Hospital June 1977 - June 1985
Skills
Cardiology, Clinical, Clinical Trials, Cardiac, Electrophysiology, Clinical Research, ICU, FDA, Nursing, Healthcare, Medical Devices, Medical/Surgical, Neurology, Hospitals, Interventional..., Medical Imaging, Orthopedic, Pacemakers, Radiology, Hardware Diagnostics, Cath Lab, Medicine, Surgery, Operating Room, ACLS, Medical-Surgical, Wound Care, Vascular, Interventional Radiology, Biomedical Engineering, BLS, Capital Equipment, Critical Care
Education
California State University Stanislaus 1978 — 1980
BSN, Nursing
San Joaquin Delta College 1975 — 1977
ADN, Nursing
ZipLine Medical January 2013 - Present
Silk Road Medical June 2007 - December 2012
Paracor Medical, Inc. April 2003 - June 2007
Atrionix, Inc. / J&J Biosense 1997 - 2002
Cardima 1993 - 1997
Advanced Cardiovascular Systems (Guidant, Abbott) 1989 - 1993
Skills
Electrophysiology, Interventional..., Heart Failure, Catheters, R&D, FDA, Medical Devices, Biomedical Engineering, Design Control, ISO 13485, V&V, Commercialization, PMA, Quality System, CE marking, Validation, Clinical Trials, ISO 14971, Regulatory Affairs, Start-ups
Education
California Polytechnic State University-San Luis Obispo
BSME
University of the Pacific
EFI April 2013 - Present
EFI July 2010 - March 2013
Cardima July 2007 - July 2010
Technology Credit Union April 2005 - July 2007
Skills
Product Marketing, Marketing, Email Marketing, Product Launch, Marketing Communications, Cross-functional Team..., Marketing Strategy, Multi-channel Marketing, Go-to-market Strategy, Adobe Creative Suite, Content Development, Trade Shows, Lead Generation, Salesforce.com, Vendor Management..., Content Writing, Outbound Marketing, B2B, Competitive Analysis, Product Management, Sitecore, Strategic Partnerships
Education
Nov Bulgarski Universitet 1997 — 2001
Law
High School Geo Milev, Dobrich 1992 — 1997
English Language, 4.0
University of California, Berkeley
Certification Program, Marketing
Dexcom August 2010 - Present
Broncus Technologies January 2009 - August 2010
PhotoThera January 2008 - October 2008
Guidant/Abbott Vascular Devices April 2000 - December 2007
Guidant 2000 - 2007
Cardima September 1997 - April 2000
St. Jude Medical - Pacesetter Inc. May 1994 - September 1997
Intermedics November 1989 - April 1994
Thiokol July 1988 - November 1989
Skills
Design Control, FDA, Medical Devices, ISO 13485, Post Market Surveillance
Education
The University of Texas at Arlington 1984 — 1988
BSAE, Aerospace Engineering
Genentech January 2014 - Present
Abbott January 2013 - November 2013
Space Systems Loral November 2010 - October 2012
American Medical Systems September 2010 - November 2010
Cardima March 2010 - September 2010
St. Jude Medical October 2007 - August 2009
Beckman Coulter August 2003 - July 2007
ERC INCORPORATED September 1997 - June 2003
Skills
Design for Manufacturing, Manufacturing..., Lean Manufacturing, Solidworks, Root Cause Analysis, Pro Engineer, Medical Devices, Manufacturing, Project Management, Machining, GD&T, Continuous Improvement, FDA, CAPA, V&V, Microsoft Office, Solid Modeling, Interpersonal..., Outlook, Fixture Design, Sheet Metal, Minitab, ISO 13485, ISO, Engineering, Cross-functional Team..., Machine Tools, Quality Assurance, Pronto Place, JMP, GR&R, 3D Printing, Validation, Measurement System..., R, Process Improvement, Design Control, SolidWorks
Education
University of North Carolina at Charlotte
Master of Science, Mechanical Engineering
National Taiwan University
Bachelor of Science, Mechanical Engineering
Bollywood Styles & Spices August 2011 - Present
Bollywood styles & Spices February 1991 - January 2014
Cardima August 2007 - December 2012
CARDIMA INC. FREMONT, CA March 2003 - August 2007
CARDIMA INC. FREMONT, CA November 2000 - March 2003
CARDIMA INC. FREMONT, CA May 1999 - November 2000
US Surgical June 1997 - April 1999
HUMPHREY INSTRUMENTS1995-1997 July 1995 - June 1997
RAYCHEM CORPORATION, Menlo Park, CA March 1983 - June 1995
Skills
R&D, Product Development, Materials, ISO 13485, FDA, CAPA, Solidworks, Quality Systems, FMEA, Validation, GMP, Design Control, Process Improvement, DOE, Design for Manufacturing, Problem Solving, Lean Manufacturing, Process Validation, ISO, Medical Devices, Design of Experiments, Injection Molding, Quality Engineering, Medical Device Product..., 510 K, Product Launch, Clinical Trials, Documentation, Clinical, Root Cause Analysis, QSR, SPC, Process Development, Quality Assurance, Manufacturing..., Manufacturing Management, Continuous Improvement, Cross-functional Team..., Engineering Management, cGMP, V&V, Quality System, Engineering, DMAIC, Process Simulation, Quality Control, SolidWorks
Education
Cogswell Polytechnical College 1988 — 1993
BS, Mechanical Engineer
Cogswell Polytechnical College 1987 — 1991
Bachelors of Science in mechanical
Shockwave Medical March 2015 - Present
Cardinal Health September 2010 - March 2015
Cardima May 2008 - September 2010
Boston Scientific 2004 - 2008
Guidant 2002 - 2005
AFx 2003 - 2004
CTS 1999 - 2003
Norian Corp 1990 - 1998
Skills
Design Control, CAPA, FMEA, Medical Devices, Root Cause Analysis, GMP, ISO 13485, Catheters, V&V, Design of Experiments, Quality System, CE marking, Biomedical Engineering, Quality Management, Validation, FDA, Minitab, R&D, Design for Manufacturing, ISO, Quality Auditing, ISO 14971, DMAIC, Lean Manufacturing, SPC, Quality Control, Manufacturing...
Education
San Jose State University 1996 — 2002
BS, Industrial Tech (Quality Assurance) Minor: Business Management
Genentech September 2013 - Present
SAP August 2011 - August 2013
Boehringer Ingelheim January 2010 - August 2011
Cardima May 2008 - January 2010
Education
University of San Francisco 2012 — 2015
Master of Business Administration (M.B.A.), Finance, General, 3.96
Pitzer College 1997 — 2001
Bachelor's Degree, Biochemistry
Cryotech International March 2011 - Present
geometrics September 2010 - March 2011
Cardima July 2008 - September 2010
Hospira October 2005 - July 2008
Celerity Systems April 2001 - May 2002
Continuum Electro-Optics January 2001 - April 2001
Integrated Packaging Assembly Corp April 1997 - December 2000
Alphatec USA March 1994 - April 1997
Carson's Coatings January 1994 - March 1994
San Joaquin Delta College September 1993 - January 1994
Skills
Solidworks, Product Design, Machining, Solid Modeling, R&D, Product Development, Testing, Catia, Mechanical Engineering, Design Engineering, Machine Tools, AutoCAD, Solid Edge, Engineering Design, Fixtures, Design for Manufacturing, Product Lifecycle..., Electronics Packaging, Design Control, Medical Devices, Six Sigma, ISO 13485, Injection Molding, SPC, CAD, Sheet Metal, Lean Manufacturing, ISO, Prototype, FDA
Education
San Joaquin Delta College 1989 — 1993
AA, Mechanical Design Drafting Technology
Thoratec October 2010 - Present
Cardima January 2000 - September 2010
CORDIS CORP/ A J&J Company January 1999 - October 1999
ORATEC INVERVENTION INC July 1998 - January 1999
CARDIOMETRICS INC June 1996 - March 1998
Skills
Solidworks, R&D, Manufacturing, Product Development, Quality System, V&V, Medical Devices, Engineering, GMP, Testing, FMEA, Design of Experiments, Catheters, Root Cause Analysis, Machining, Biomedical Engineering
Education
Computer Business Center 1995 — 1996
Ceritificate, Computer
Evergreen Valley College 1993 — 1994
Computer Info System stutent
William C. Overfelt High School San Jose, CA 1990 — 1993
High School Diploma
Beauty Salon & Barber. 2015 - Present
CNC Machining 2001 - Present
Baxano June 2008 - November 2012
Avantis Medical Systems 2006 - 2008
Lumend 2003 - 2005
Cardima 1996 - 1999
ArthroCare Corporation 1992 - 1995
Skills
Lean Manufacturing, Problem Solving, Product Development, Excel, Team Leadership, Production Planning, Supervisory Skills, Solidworks, AutoCAD Mechanical, Pro Engineer, Microsoft Excel, R&D
Education
De Anza College 1998 — 2001
Computer Aided Design-Mechanical
Cosmetology College
Licensed
Thermo Fisher Scientific June 2014 - Present
Stryker Neurovascular December 2013 - April 2014
DePuy Synthes (Johnson&Johnson Company) April 2013 - July 2013
SEA Medical Inc. September 2012 - April 2013
Surpass Medical Inc. September 2011 - August 2012
Spinal Kinetics February 2007 - February 2011
Aviir, Inc. July 2007 - January 2009
Cardima September 2005 - July 2007
ArthroCare Corporation July 2004 - September 2005
Naxcor Inc. September 2002 - June 2004
Skills
Strategy, Life Sciences, Analysis, Project Management, Biotechnology, Data Analysis, Quality System, FDA, Quality Assurance, CAPA, ISO, Continuous Improvement, Quality Auditing, ISO 13485, Medical Devices, SPC, Manufacturing, GMP, Cross-functional Team...
Education
San Jose State University 1985 — 1987
MS Industrial Engineering -, Quality Assurance
State University of New York College at Plattsburgh
Bachelor of Arts (B.A.), Chemistry