Ebrahim L Fadakar

Ebrahim Fadakar San Jose, CA

view source

Work:

Medina Medical
Menlo Park, CA
Feb 2014 to May 2014 Bayer Diabetes Care
Sunnyvale, CA
Jan 2012 to Jul 2013
Project Manager for Class II Medical Device Manufacture Abbott Vascular
Santa Clara, CA
Jan 2011 to Dec 2011
Validation engineer Boston Scientific Neurovascular Interventional Cardiology
Fremont, CA
Sep 2009 to Oct 2010
Validation engineer for "Class III" surgical medical device Hologic
Redwood City, CA
Jan 2009 to Aug 2009
Quality engineer Quality systems analystRedwood City, CA
May 2008 to Jan 2009 Boston Scientific Cardiac Surgery
Santa Clara, CA
Aug 2007 to Apr 2008
Quality systems analyst for "Class II&III Thermo fisher Scientific
Fremont, CA
Jan 2007 to Jul 2007
Quality systems auditor for "protein-based" drugs Manufacturer Esterline
Buena Park, CA
Feb 2006 to Dec 2006
Quality engineer for Aerospace and Defense Allergan
Irvine, CA
Jul 2005 to Feb 2006
QA analyst for new API manufacturer Biorad
Irvine, CA
Sep 2004 to Jul 2005
QA packaging analyst for medical device manufacturer QA production technicianIrvine, CA
Feb 2002 to Sep 2004 Medical

2000 to 2000

Education:

BioHealth College
San Jose, CA
May 2013
Biotechnology Laboratory Technician San Jose State University
MS in Medical Product Development Management

Ebrahim Fadakar Los Altos, CA

view source

Work:

Medina Medical

Mar 2014 to 2000
Validation Engineer for Class III Medical Device Manufacture Bayer Diabetes Care, A1CNow+ Headquarters
Sunnyvale, CA
Jan 2011 to Jul 2013
Project Manager for Class II Medical Device Manufacture ABBOTT /Vascular
Santa Clara, CA
Jan 2011 to Dec 2011
Software Quality Engineer for "Eluting Coronary Stent System" Laboratory Equipment Lifecycle process BOSTON SCIENTIFIC/ Neurovascular Interventional Cardiology
Fremont, CA
Sep 2009 to Aug 2010
Software Validation Engineer for "Class III" Surgical Medical Device HOLOGIC
Redwood City, CA
May 2008 to Aug 2009
Quality Engineer for Class III Therapeutic Surgical Medical Device Manufacturer for women's healthcare EV3,Vascular Surgery Medical Device
Redwood City, CA
May 2008 to Mar 2009
Quality Systems Analyst BOSTON SCIENTIFIC/Cardiac Surgery
Santa Clara, CA
Apr 2006 to Aug 2007
Quality Systems Analyst for Class II&III Cardiac Surgery Medical Device Manufacturer THERMOFISHER SCIENTIFIC
Fremont, CA
Jan 2007 to Jul 2007
Quality Systems Auditor for "protein-based" drugs Manufacturer ESTERLINE
Buena Park, CA
Feb 2006 to Dec 2006
Quality Engineer for Aerospace and Defense ALLERGAN
Irvine, CA
Jul 2005 to Feb 2006
QA Analyst BIO-RAD
Irvine, CA
Sep 2004 to Jul 2005
QA Packaging TEVA
Irvine, CA
Feb 2002 to Sep 2004
QA / Production Technician

Education:

San Jose State University
San Jose, CA
Jan 2010 to Jan 2013
Medical Product Development Management (MPDM) in Medical ASQ
Orange, CA
Jan 2005 to Jan 2006
Quality System Auditor in Quality Assurance Cal. State Fullerton
Fullerton, CA
Jan 2003 to Jan 2005
Certificate in Pharmaceutical Engineering in Fashion Design Cal. State Long Beach
Long Beach, CA
Jan 1992 to Jan 1995
B.A In Textile and Clothing in Art

Skills:

IN-HOUSE TRAINING CLASSES PERFORMED Regulatory Submissions: Devices & Diagnostics ISO [] Compliances CER Testing & Monitoring [] (Medical/electrical equipment safety standards) IVDD 98/79/EC, MDD-EEC 93/42/EEC FDA 21CFR part 820 Compliance FDA/ISO Biocompatibility Testing FDA HACCP & QSIT IEC 62304 Medical device software life cycle IEC 62366 Usability ISO [] supply of software [] bases for software validation ISO vs. FDA Standards Comparison FDA 21CFR11 Compliance MDD 93/42/EEC & IVD 98/79/EC Compliance Canadian Medical Device Conformity Assessment ISO 14644 Clean Room Validation ISO 14971 Risk Management FMEA SKILLS Windows, Linux, Unix, Androids OS Java and J2EE, Python , C and C++, SQL, Assembly .NET technologies including ASP, WPF, WCF, WF and LINQ in C# Statistical Tools: Minitab16, IBM SASJMP9, SPSS and R Autodesk Products(AutoCAD/3DMAX/Maya, Auto- lips), Light -wave, Adobe Creative Suite, Corel X, Crystal Reports and Excel Graphic Charts

Ebrahim Fadakar San Jose, CA

view source

Work:

Bayer Diabetes Care
Sunnyvale, CA
Jan 2012 to Jul 2013
QA ABBOTT /Vascular
Santa Clara, CA
Jan 2011 to Dec 2011
QA for "Eluting Coronary Stent System" Laboratory BOSTON SCIENTIFIC/ Neurovascular Interventional Cardiology
Fremont, CA
Sep 2009 to Mar 2010
QA for "Class III" Surgical Medical Device HOLOGIC
Redwood City, CA
Jan 2009 to Aug 2009
QA for "Class III" Therapeutic Surgical Medical Device Manufacturer Vascular Surgery Medical Device
Redwood City, CA
May 2008 to Jan 2009
Quality Systems Analyst for "Class II" BOSTON SCIENTIFIC/Cardiac Surgery
Santa Clara, CA
Aug 2007 to Apr 2008
Quality Systems Analyst for "Class II&III" Cardiac Surgery Medical Device Manufacturer THERMOFISHER SCIENTIFIC
Fremont, CA
Jan 2007 to Jul 2007
Quality Systems Auditor for "protein-based" drugs Manufacturer ESTERLINE
Buena Park, CA
Feb 2006 to Dec 2006
QA for Aerospace and Defense ALLERGAN
Irvine, CA
Jul 2005 to Feb 2006
QA Analyst for New API Manufacturer BIORAD
Irvine, CA
Sep 2004 to Jul 2005
QA Packaging for Medical Device Manufacturer TEVA
Irvine, CA
Feb 2002 to Sep 2004
QA / Production Technician TEVA -
Irvine, CA
2000 to 2000
QA / Production Technician

Education: