Safestitch Medical
Industry: Company
DescriptionHeadquarters: Morrisville, NC Executive vice president: Joseph P. Slattery CFO: Joseph P. Slattery COO: Anthony Fernando Subsidiaries: SafeStitch LLC, Isis Tele Communications Inc, VPs: Nicole Bell, Stephanie Fitts (Clinical, Quality, Regulatory Affairs), Kathleen Frost
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Safestitch Medical Employees
Employee
Years
Job
Industry
Michelle Espinoza, MAcc, C.P.A. Michelle Espinoza, MAcc, C.P.A.'s Safestitch Medical Experience December 2008 - June 2010
Job Staff Accountant
Industry Accounting
Experience
McCartney & Company, P.C. November 2011 - Present
Pratt & Whitney Auto Air (Total Technical Services) February 2011 - November 2011
Safestitch Medical December 2008 - June 2010
Doug Granger, C.P.A. November 2007 - August 2008
Menendez & Navia, C.P.A. October 2005 - November 2006
Skills
Quickbooks, Creative Solutions, SAP, Microsoft Office, Great Plains, Variance Analysis, General Ledger, US GAAP, Financial Accounting, Financial Reporting, QuickBooks, Consolidation, Accounting, Account Reconciliation, Great Plains Software, GAAP, Accounts Payable, Accounts Receivable, Auditing, CPA, Sarbanes-Oxley Act, Tax, Internal Controls, Peachtree, Fixed Assets, Tax Preparation
Education
Nova Southeastern University 2009 — 2011
MAcc, Accouting
Florida International University 2002 — 2006
BA, Accounting
McCartney & Company, P.C. November 2011 - Present
Pratt & Whitney Auto Air (Total Technical Services) February 2011 - November 2011
Safestitch Medical December 2008 - June 2010
Doug Granger, C.P.A. November 2007 - August 2008
Menendez & Navia, C.P.A. October 2005 - November 2006
Skills
Quickbooks, Creative Solutions, SAP, Microsoft Office, Great Plains, Variance Analysis, General Ledger, US GAAP, Financial Accounting, Financial Reporting, QuickBooks, Consolidation, Accounting, Account Reconciliation, Great Plains Software, GAAP, Accounts Payable, Accounts Receivable, Auditing, CPA, Sarbanes-Oxley Act, Tax, Internal Controls, Peachtree, Fixed Assets, Tax Preparation
Education
Nova Southeastern University 2009 — 2011
MAcc, Accouting
Florida International University 2002 — 2006
BA, Accounting
Jason Barrocas Jason Barrocas's Safestitch Medical Experience January 2012 - August 2012
Job Product Development Engineer
Industry Medical Devices
Experience
Safestitch Medical January 2012 - August 2012
Safestitch Medical April 2011 - January 2012
Syntheon LLC February 2010 - March 2011
Skills
Design Verification..., Design of Experiments, Root Cause Analysis, Test Method Validation, Product Specification, Team Leadership, Engineering Study..., SolidWorks, CAD, Minitab, Microsoft Office, Design Control, Product Development, Process Capability, Tool Assessment, GD&T, Tolerance Analysis, GDP, GMP, Solidworks, Engineering
Education
Florida International University
Bachelor of Science (BS), Mechanical Engineering
Safestitch Medical January 2012 - August 2012
Safestitch Medical April 2011 - January 2012
Syntheon LLC February 2010 - March 2011
Skills
Design Verification..., Design of Experiments, Root Cause Analysis, Test Method Validation, Product Specification, Team Leadership, Engineering Study..., SolidWorks, CAD, Minitab, Microsoft Office, Design Control, Product Development, Process Capability, Tool Assessment, GD&T, Tolerance Analysis, GDP, GMP, Solidworks, Engineering
Education
Florida International University
Bachelor of Science (BS), Mechanical Engineering
Maria-Elena Diaz Maria-Elena Diaz's Safestitch Medical Experience January 2012 - May 2015
Job Quality Technician at Beckman Coulter
Industry Medical Devices
Experience
Beckman Coulter April 2015 - Present
Safestitch Medical January 2012 - May 2015
MedVenture Technology November 2007 - December 2010
Micrus Endovascular January 2003 - June 2007
Medtronic January 2000 - November 2002
Skills
Medical Devices, FDA, ISO 13485, Quality System, ISO, Product Development, R&D, Design of Experiments, GMP, Minitab, Quality Assurance, Validation, Manufacturing, Quality Control, Lean Manufacturing, Catheters
Education
Miami Dade College
Other
Beckman Coulter April 2015 - Present
Safestitch Medical January 2012 - May 2015
MedVenture Technology November 2007 - December 2010
Micrus Endovascular January 2003 - June 2007
Medtronic January 2000 - November 2002
Skills
Medical Devices, FDA, ISO 13485, Quality System, ISO, Product Development, R&D, Design of Experiments, GMP, Minitab, Quality Assurance, Validation, Manufacturing, Quality Control, Lean Manufacturing, Catheters
Education
Miami Dade College
Other
Manny Calvo Manny Calvo's Safestitch Medical Experience February 2011 - July 2012
Job Engineering / Manufacturing Manager at Surgimed Corporation
Industry Hospital & Health Care
Experience
Surgimed Corporation January 2013 - Present
Safestitch Medical February 2011 - July 2012
Surgimed Corporation October 2008 - August 2011
KSM Electronics February 2007 - January 2008
Cordis 2001 - 2007
Baxter Healthcare 1997 - 2001
Beckman Coulter 1985 - 1997
PerkinElmer 1980 - 1985
Skills
Medical Devices, FDA, ISO 13485, Design Control, Quality System, Product Development, Lean Manufacturing, ISO, R&D, Manufacturing, Engineering, Validation, Continuous Improvement
Education
FIU 2002 — 2004
Master of Engineering Management, Engineering/Industrial Management
Illinois Institute of Technology 1982 — 1986
Bachelor in Mechanical Engineering, Mechanical Engineering
Triton College 1980 — 1982
Associate of Science (A.S.), Mechanical Design Engineering, 3.3
Surgimed Corporation January 2013 - Present
Safestitch Medical February 2011 - July 2012
Surgimed Corporation October 2008 - August 2011
KSM Electronics February 2007 - January 2008
Cordis 2001 - 2007
Baxter Healthcare 1997 - 2001
Beckman Coulter 1985 - 1997
PerkinElmer 1980 - 1985
Skills
Medical Devices, FDA, ISO 13485, Design Control, Quality System, Product Development, Lean Manufacturing, ISO, R&D, Manufacturing, Engineering, Validation, Continuous Improvement
Education
FIU 2002 — 2004
Master of Engineering Management, Engineering/Industrial Management
Illinois Institute of Technology 1982 — 1986
Bachelor in Mechanical Engineering, Mechanical Engineering
Triton College 1980 — 1982
Associate of Science (A.S.), Mechanical Design Engineering, 3.3
Claudio Pacella Claudio Pacella's Safestitch Medical Experience February 2012 - July 2012
Job Production Mechanic at Nipro Diagnostics (formerly Home Diagnostics)
Industry Medical Devices
Experience
Nipro Diagnostics (formerly Home Diagnostics) October 2012 - Present
Safestitch Medical February 2012 - July 2012
Boston Scientific November 2008 - January 2012
Cordis Corp. April 2002 - October 2008
Nortel Networks 1986 - 2001
Skills
ISO 13485, Medical Devices, Design Control, FDA, V&V, CAPA, Manufacturing, Product Development, Quality System, Validation, Root Cause Analysis, GMP, FMEA, Lean Manufacturing, Six Sigma, Design of Experiments
Education
Dawson College 1985 — 1988
Nipro Diagnostics (formerly Home Diagnostics) October 2012 - Present
Safestitch Medical February 2012 - July 2012
Boston Scientific November 2008 - January 2012
Cordis Corp. April 2002 - October 2008
Nortel Networks 1986 - 2001
Skills
ISO 13485, Medical Devices, Design Control, FDA, V&V, CAPA, Manufacturing, Product Development, Quality System, Validation, Root Cause Analysis, GMP, FMEA, Lean Manufacturing, Six Sigma, Design of Experiments
Education
Dawson College 1985 — 1988
scott Arp scott Arp's Safestitch Medical Experience February 2007 - December 2009
Job Engineering Consultant
Industry Medical Devices
Experience
Arp Consulting Inc. (Sole Proprietorship) December 2011 - Present
Naglreiter Consulting LLC October 2011 - Present
Syntheon LLC January 2009 - February 2012
Safestitch Medical February 2007 - December 2009
Innovia LLC January 2005 - February 2007
Syntheon LLC March 2002 - January 2005
Medcanica LLC April 2000 - March 2002
Mark Two Engineering February 1998 - April 2000
Micro Med Machining August 1995 - February 1998
Skills
Medical Devices, Solidworks, FDA, Validation, Design of Experiments, Root Cause Analysis, V&V, Lean Manufacturing, Manufacturing, R&D, GMP, ISO 13485, Product Development, Testing, Product Design, Machining, Injection Molding, Process Improvement, CAPA, Minitab, Software Documentation, Design Control, Engineering, Quality System, Cnc, GD&T, FMEA, Sop, Biomedical Engineering, Design for Manufacturing, Quality Control, Plastics, Product Launch, Biomaterials, CAD, Catheters, Project Planning, Manufacturing..., Process Simulation
Education
Florida International University
Mechanical Engineering
Miami Dade College
A.A., Engineering
Arp Consulting Inc. (Sole Proprietorship) December 2011 - Present
Naglreiter Consulting LLC October 2011 - Present
Syntheon LLC January 2009 - February 2012
Safestitch Medical February 2007 - December 2009
Innovia LLC January 2005 - February 2007
Syntheon LLC March 2002 - January 2005
Medcanica LLC April 2000 - March 2002
Mark Two Engineering February 1998 - April 2000
Micro Med Machining August 1995 - February 1998
Skills
Medical Devices, Solidworks, FDA, Validation, Design of Experiments, Root Cause Analysis, V&V, Lean Manufacturing, Manufacturing, R&D, GMP, ISO 13485, Product Development, Testing, Product Design, Machining, Injection Molding, Process Improvement, CAPA, Minitab, Software Documentation, Design Control, Engineering, Quality System, Cnc, GD&T, FMEA, Sop, Biomedical Engineering, Design for Manufacturing, Quality Control, Plastics, Product Launch, Biomaterials, CAD, Catheters, Project Planning, Manufacturing..., Process Simulation
Education
Florida International University
Mechanical Engineering
Miami Dade College
A.A., Engineering
Raul Travieso Raul Travieso's Safestitch Medical Experience November 2011 - August 2012
Job CTO at Phiston Technologies, Inc.
Industry Mechanical or Industrial Engineering
Experience
Phiston Technologies July 2014 - Present
Engineering Contractor August 2012 - July 2014
Safestitch Medical November 2011 - August 2012
Beckman Coulter January 2002 - November 2011
Beckman Coulter January 1995 - January 2002
Cordis January 1993 - January 1995
Baxter International Inc. January 1992 - January 1993
Baxter International Inc. January 1990 - January 1992
Telectronics January 1989 - January 1990
Cordis January 1987 - January 1989
Skills
ISO 13485, Design Control, Solidworks, R&D, Medical Devices, FDA, Manufacturing, Six Sigma, Engineering, Product Development, Continuous Improvement, Lean Manufacturing, Design for Manufacturing, Cross-functional Team..., Product Design, Mechanical Engineering, CAD, Validation, Testing, ISO, SolidWorks
Education
Florida International University 1983 — 1987
Bachelor of Science (B.S.), College of Mechanical Engineering
Florida International University - College of Business Administration
Advanced Project Management
Florida International University - College of Business Administration
Supervisory Certificate Program
Phiston Technologies July 2014 - Present
Engineering Contractor August 2012 - July 2014
Safestitch Medical November 2011 - August 2012
Beckman Coulter January 2002 - November 2011
Beckman Coulter January 1995 - January 2002
Cordis January 1993 - January 1995
Baxter International Inc. January 1992 - January 1993
Baxter International Inc. January 1990 - January 1992
Telectronics January 1989 - January 1990
Cordis January 1987 - January 1989
Skills
ISO 13485, Design Control, Solidworks, R&D, Medical Devices, FDA, Manufacturing, Six Sigma, Engineering, Product Development, Continuous Improvement, Lean Manufacturing, Design for Manufacturing, Cross-functional Team..., Product Design, Mechanical Engineering, CAD, Validation, Testing, ISO, SolidWorks
Education
Florida International University 1983 — 1987
Bachelor of Science (B.S.), College of Mechanical Engineering
Florida International University - College of Business Administration
Advanced Project Management
Florida International University - College of Business Administration
Supervisory Certificate Program
JC Campbell's Safestitch Medical Experience March 2009 - August 2012
Job Financial Strategies Group
Industry Financial Services
Experience
Financial Advisor at Financial Strategies Group January 2014 - Present
Independent Medical sales Rep March 2013 - January 2014
AUTOMATION & ROBOTICS August 2012 - February 2013
Safestitch Medical March 2009 - August 2012
Consultation February 2007 - February 2009
St. Jude Medical January 2005 - February 2007
Pfizer Pharmaceuticals September 2001 - January 2005
Pfizer November 1997 - September 2001
Skills
Financial Analysis, Financial Planning, Financial Services, Securities, 401k Rollovers, IRAs, Roth IRA, Simple IRA, Financial Accounting, 529 Plans, Individual Pension Plans, Wealth Management, Wealth Management..., Stockbroking, Stock Market, Stock Trading, Stock Exchange
Education
The University of Tennessee at Chattanooga 2009 — 2011
Advance Accounting
University of Louisiana at Monroe 1989 — 1994
Bachelor's degree, Business Administration and Management, General
Financial Advisor at Financial Strategies Group January 2014 - Present
Independent Medical sales Rep March 2013 - January 2014
AUTOMATION & ROBOTICS August 2012 - February 2013
Safestitch Medical March 2009 - August 2012
Consultation February 2007 - February 2009
St. Jude Medical January 2005 - February 2007
Pfizer Pharmaceuticals September 2001 - January 2005
Pfizer November 1997 - September 2001
Skills
Financial Analysis, Financial Planning, Financial Services, Securities, 401k Rollovers, IRAs, Roth IRA, Simple IRA, Financial Accounting, 529 Plans, Individual Pension Plans, Wealth Management, Wealth Management..., Stockbroking, Stock Market, Stock Trading, Stock Exchange
Education
The University of Tennessee at Chattanooga 2009 — 2011
Advance Accounting
University of Louisiana at Monroe 1989 — 1994
Bachelor's degree, Business Administration and Management, General
George L. Lara's Safestitch Medical Experience January 2012 - June 2012
Job Sr Quality Associate
Industry Medical Devices
Experience
Codman July 2013 - Present
Safestitch Medical January 2012 - June 2012
JOHNSON and JOHNSON – CORDIS CORPORATION October 1995 - August 2011
Cordis Corporation October 1998 - June 2005
TELECTRONIC PACING SYSTEM January 1994 - January 1995
Skills
Validation, Software Installation, ISO 13485, Medical Devices, FDA, Design Control, Quality System, Design of Experiments, Calibration, GMP, Minitab, Biomedical Engineering, R&D, CompTIA A+ Certification, ADAPTIV PLM..., Testing, Quality Control, Manufacturing, Process Improvement, Six Sigma, Software Documentation, Product Development, DMAIC, Electronics, Engineering, FMEA, ISO 14971, SPC, Quality Assurance, Root Cause Analysis
Education
Miami Dade College 1998 — 2000
AS, Electronics Engineering Technology
Passaic school of drafting 1990 — 1992
Electro/mechanical draftsman, Electrical and mechanical drafting
Codman July 2013 - Present
Safestitch Medical January 2012 - June 2012
JOHNSON and JOHNSON – CORDIS CORPORATION October 1995 - August 2011
Cordis Corporation October 1998 - June 2005
TELECTRONIC PACING SYSTEM January 1994 - January 1995
Skills
Validation, Software Installation, ISO 13485, Medical Devices, FDA, Design Control, Quality System, Design of Experiments, Calibration, GMP, Minitab, Biomedical Engineering, R&D, CompTIA A+ Certification, ADAPTIV PLM..., Testing, Quality Control, Manufacturing, Process Improvement, Six Sigma, Software Documentation, Product Development, DMAIC, Electronics, Engineering, FMEA, ISO 14971, SPC, Quality Assurance, Root Cause Analysis
Education
Miami Dade College 1998 — 2000
AS, Electronics Engineering Technology
Passaic school of drafting 1990 — 1992
Electro/mechanical draftsman, Electrical and mechanical drafting
Jaime Franco's Safestitch Medical Experience January 2010 - August 2012
Job Sr Manufacturing Engineering Technician at HeartWare
Industry Medical Devices
Experience
HeartWare Inc 2012 - 2014
SafeStitch Medical January 2010 - August 2012
Cordis, Johnson & Johnson January 1992 - January 2010
Skills
FTIR, Design Control, ISO 13485, Medical Devices, V&V, FDA, CAPA, Validation, GMP, Design of Experiments, Minitab, Biomedical Engineering, Quality System, R&D, FMEA, Manufacturing, Commercialization, Product Launch, Failure Analysis, Product Development, Solidworks, Root Cause Analysis, Design for Manufacturing, ISO, DMAIC, ISO 14971, Process Simulation, Calibration, Quality Control, Lean Manufacturing, Change Control, SPC, Quality Assurance, 21 CFR Part 11, Manufacturing...
Education
Miami Dade College 1998 — 2002
AS, Electronic Engineering Technology
HeartWare Inc 2012 - 2014
SafeStitch Medical January 2010 - August 2012
Cordis, Johnson & Johnson January 1992 - January 2010
Skills
FTIR, Design Control, ISO 13485, Medical Devices, V&V, FDA, CAPA, Validation, GMP, Design of Experiments, Minitab, Biomedical Engineering, Quality System, R&D, FMEA, Manufacturing, Commercialization, Product Launch, Failure Analysis, Product Development, Solidworks, Root Cause Analysis, Design for Manufacturing, ISO, DMAIC, ISO 14971, Process Simulation, Calibration, Quality Control, Lean Manufacturing, Change Control, SPC, Quality Assurance, 21 CFR Part 11, Manufacturing...
Education
Miami Dade College 1998 — 2002
AS, Electronic Engineering Technology
Juan Carlos Sandoval's Safestitch Medical Experience January 2012 - Present
Job Medical Device Principal Technician
Industry Medical Devices
Experience
SafeStitch Medical January 2012 - Present
Safestitch Medical 2012 - 2012
Cordis Corporation a Johnson and Johnson Company October 1990 - August 2011
Cordis January 1996 - January 1997
Cordis January 1994 - January 1996
Cordis January 1992 - January 1994
Cordis January 1990 - January 1992
DELLARIZZA ENGINEERING CONSULTANTS May 1990 - October 1990
Florida International University January 1988 - January 1990
Skills
Scanning Electron..., Design of Experiments, Design Control, Medical Devices, V&V
Education
South Carolina State University 1982 — 1985
B.S, Mechanical Engineering Technology
SafeStitch Medical January 2012 - Present
Safestitch Medical 2012 - 2012
Cordis Corporation a Johnson and Johnson Company October 1990 - August 2011
Cordis January 1996 - January 1997
Cordis January 1994 - January 1996
Cordis January 1992 - January 1994
Cordis January 1990 - January 1992
DELLARIZZA ENGINEERING CONSULTANTS May 1990 - October 1990
Florida International University January 1988 - January 1990
Skills
Scanning Electron..., Design of Experiments, Design Control, Medical Devices, V&V
Education
South Carolina State University 1982 — 1985
B.S, Mechanical Engineering Technology
Martha A Moreno's Safestitch Medical Experience February 2012 - June 2012
Job Quality Systems Engineer / Supervisor at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical August 2013 - Present
Aveva Drug Delivery Systems May 2013 - August 2013
HeartWare Inc July 2012 - December 2012
Safestitch Medical February 2012 - June 2012
Boston Scientific March 2010 - January 2012
Dayton-Granger, Inc. October 2007 - August 2009
Dayton-Granger, Inc. October 2006 - October 2007
Skills
Quality System, Quality Assurance, Lean Manufacturing, Root Cause Analysis, CAPA, FDA, V&V, Validation, Minitab, Engineering Drawings, FMEA, Value Stream Mapping, Manufacturing, Six Sigma, DMAIC, Engineering, Manufacturing..., Quality Control, Cross-functional Team..., Team Leadership, ISO, SAP, Supervisory Skills, MRP, Equipment Qualification, Process Validation, Creative Problem Solving, Initiator, Multitasker
Education
Polytechnic University of Puerto Rico 2011 — 2015
M.S. in Engineering Management, Manufacturing Engineering, 3.85
Unilatina International College 2006 — 2007
Diploma Program, Small Business Management
Universidad Industrial de Santander 2001 — 2005
Bachelor of Science (B.S.), Industrial Engineering, 4.0
Bolton Medical August 2013 - Present
Aveva Drug Delivery Systems May 2013 - August 2013
HeartWare Inc July 2012 - December 2012
Safestitch Medical February 2012 - June 2012
Boston Scientific March 2010 - January 2012
Dayton-Granger, Inc. October 2007 - August 2009
Dayton-Granger, Inc. October 2006 - October 2007
Skills
Quality System, Quality Assurance, Lean Manufacturing, Root Cause Analysis, CAPA, FDA, V&V, Validation, Minitab, Engineering Drawings, FMEA, Value Stream Mapping, Manufacturing, Six Sigma, DMAIC, Engineering, Manufacturing..., Quality Control, Cross-functional Team..., Team Leadership, ISO, SAP, Supervisory Skills, MRP, Equipment Qualification, Process Validation, Creative Problem Solving, Initiator, Multitasker
Education
Polytechnic University of Puerto Rico 2011 — 2015
M.S. in Engineering Management, Manufacturing Engineering, 3.85
Unilatina International College 2006 — 2007
Diploma Program, Small Business Management
Universidad Industrial de Santander 2001 — 2005
Bachelor of Science (B.S.), Industrial Engineering, 4.0
Will Duenas's Safestitch Medical Experience June 2008 - February 2013
Job Research & Development Engineer at Skeletal Dynamics, LLC
Industry Medical Devices
Experience
Skeletal Dynamics, LLC February 2013 - Present
SafeStitch Medical June 2008 - February 2013
Pilot Training Center 2013 - 2013
Mark Two Engineering September 1998 - April 2008
Skills
Pro/Engineer, Solidworks, CNC, Mastercam, Medical Devices, Manufacturing, ISO, Engineering, Components, Aerospace, Product Development, Design for Manufacturing, GD&T, Machining, Process Qualification, FMEA, Tolerance Analysis, Geometric Dimensioning..., Root Cause Analysis, Pro Engineer, Cnc, Testing, R&D, Minitab, Quality System, ISO 13485, FDA, Design of Experiments, Lean Manufacturing, Design Control, Finite Element Analysis, Manufacturing..., CAD, CAD/CAM, Six Sigma, V&V, Product Design, Engineering Management, Mechanical Engineering, Injection Molding, Rapid Prototyping, ISO 14971, CAPA, Validation, Product Launch, Quality Control, Surgical Instruments, Plastics, SolidWorks
Education
Florida International University 1996 — 2004
BS, Mechanical Engineering
Skeletal Dynamics, LLC February 2013 - Present
SafeStitch Medical June 2008 - February 2013
Pilot Training Center 2013 - 2013
Mark Two Engineering September 1998 - April 2008
Skills
Pro/Engineer, Solidworks, CNC, Mastercam, Medical Devices, Manufacturing, ISO, Engineering, Components, Aerospace, Product Development, Design for Manufacturing, GD&T, Machining, Process Qualification, FMEA, Tolerance Analysis, Geometric Dimensioning..., Root Cause Analysis, Pro Engineer, Cnc, Testing, R&D, Minitab, Quality System, ISO 13485, FDA, Design of Experiments, Lean Manufacturing, Design Control, Finite Element Analysis, Manufacturing..., CAD, CAD/CAM, Six Sigma, V&V, Product Design, Engineering Management, Mechanical Engineering, Injection Molding, Rapid Prototyping, ISO 14971, CAPA, Validation, Product Launch, Quality Control, Surgical Instruments, Plastics, SolidWorks
Education
Florida International University 1996 — 2004
BS, Mechanical Engineering
Alina Caraballo's Safestitch Medical Experience October 2010 - Present
Job Founder and CEO at Caraballo Consulting
Industry Medical Devices
Experience
Caraballo Consulting November 2012 - Present
Safestitch Medical October 2010 - Present
Cordis March 1998 - September 2010
Skills
ISO 13485, Design Control, FDA, Medical Devices, CAPA, Validation, Regulatory Affairs, Clinical Research, V&V, Minitab, Quality Assurance, Design of Experiments, GMP, Six Sigma, Quality System, Cross-functional Team..., Biomedical Engineering, FMEA, Product Launch, ISO 14971, R&D
Education
Florida International University
Bachelor's degree, Medical Technology
Caraballo Consulting November 2012 - Present
Safestitch Medical October 2010 - Present
Cordis March 1998 - September 2010
Skills
ISO 13485, Design Control, FDA, Medical Devices, CAPA, Validation, Regulatory Affairs, Clinical Research, V&V, Minitab, Quality Assurance, Design of Experiments, GMP, Six Sigma, Quality System, Cross-functional Team..., Biomedical Engineering, FMEA, Product Launch, ISO 14971, R&D
Education
Florida International University
Bachelor's degree, Medical Technology
Brandon Hunt's Safestitch Medical Experience March 2008 - August 2013
Job Director R&D, Engineering at International Medical Industries, Inc.
Industry Medical Devices
Experience
International Medical Industries, Inc. August 2014 - Present
TransEnterix, Inc. August 2013 - July 2014
Safestitch Medical March 2008 - August 2013
Phoenix Analysis and Design Technologies 2005 - 2008
Skills
Design Control, Product Development, ISO 13485, Medical Devices, FDA, V&V, CAPA, Biomedical Engineering, R&D, Quality System, Validation, Design of Experiments, Design for Manufacturing, ISO 14971, Leadership, Product Launch, FMEA, GMP, Lean Manufacturing, Pro Engineer, Product Design, Injection Molding, Root Cause Analysis, Process Simulation, Manufacturing, Solidworks, Commercialization, Minitab, ISO, Quality Assurance, GD&T, Engineering, Machining
Education
Arizona State University 2001 — 2004
BS, Mechanical Engineering
University of Phoenix
MBA, Technology Management
International Medical Industries, Inc. August 2014 - Present
TransEnterix, Inc. August 2013 - July 2014
Safestitch Medical March 2008 - August 2013
Phoenix Analysis and Design Technologies 2005 - 2008
Skills
Design Control, Product Development, ISO 13485, Medical Devices, FDA, V&V, CAPA, Biomedical Engineering, R&D, Quality System, Validation, Design of Experiments, Design for Manufacturing, ISO 14971, Leadership, Product Launch, FMEA, GMP, Lean Manufacturing, Pro Engineer, Product Design, Injection Molding, Root Cause Analysis, Process Simulation, Manufacturing, Solidworks, Commercialization, Minitab, ISO, Quality Assurance, GD&T, Engineering, Machining
Education
Arizona State University 2001 — 2004
BS, Mechanical Engineering
University of Phoenix
MBA, Technology Management
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY