Bioteknica Company
Industry: Company
DescriptionFounded: 1996
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Bioteknica Employees
Employee
Years
Job
Industry
Winnie Medina Winnie Medina's Bioteknica Experience October 2014 - Present
Job Student at Florida International University
Industry Medical Devices
Experience
BioTeknica October 2014 - Present
Skeletal Dynamics, LLC October 2013 - April 2014
Neuronal Mass Dynamics Laboratory 2013 - 2014
Skills
Matlab, Microsoft Office, Biomedical Engineering, Labview, Statistics, Physics, Mathematica, ANSYS, Microscopy, LaTeX, SolidWorks, Minitab, SPSS
Education
Florida International University 2011 — 2014
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Miami Dade College 2009 — 2011
Associate of Arts (A.A.), Biology/Biological Sciences, General
Shanghai Lixin University of Commerce 2010 — 2010
Economic Awakening Study Abroad, Macroeconomics and Microeconomics
BioTeknica October 2014 - Present
Skeletal Dynamics, LLC October 2013 - April 2014
Neuronal Mass Dynamics Laboratory 2013 - 2014
Skills
Matlab, Microsoft Office, Biomedical Engineering, Labview, Statistics, Physics, Mathematica, ANSYS, Microscopy, LaTeX, SolidWorks, Minitab, SPSS
Education
Florida International University 2011 — 2014
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Miami Dade College 2009 — 2011
Associate of Arts (A.A.), Biology/Biological Sciences, General
Shanghai Lixin University of Commerce 2010 — 2010
Economic Awakening Study Abroad, Macroeconomics and Microeconomics
Marco De Luna Marco De Luna's Bioteknica Experience December 2011 - August 2012
Job Process/Validation Engineer
Industry Medical Devices
Experience
BEPC Consulting May 2014 - September 2014
CareFusion August 2012 - January 2013
BioTeknica December 2011 - August 2012
Ethicon Endo-Surgery January 1999 - January 2007
Renault June 1995 - September 1995
Skills
Manufacturing, Product Management, Process Engineering, Process Development, Product Development, R&D, Cross-functional Team..., Six Sigma, Process Improvement, FMEA, Quality System, Design of Experiments, Program Management, Product Design, ISO, Continuous Improvement, SPC, Root Cause Analysis, Quality Assurance, GMP, Validation, ISO 13485, Design Control, CAPA, V&V, GD&T, FDA, Minitab, 5S, Process Simulation, Lean Manufacturing, Lean manufacturing, Medical Devices, Engineering, Leadership, Management, DMAIC, ISO 9000, Quality Management
Education
Universidad Regional del Norte 2002 — 2005
MBA, Operations Management
Universidad Autonoma de Zacatecas 1992 — 1997
Mechanical Engineer, Design
BEPC Consulting May 2014 - September 2014
CareFusion August 2012 - January 2013
BioTeknica December 2011 - August 2012
Ethicon Endo-Surgery January 1999 - January 2007
Renault June 1995 - September 1995
Skills
Manufacturing, Product Management, Process Engineering, Process Development, Product Development, R&D, Cross-functional Team..., Six Sigma, Process Improvement, FMEA, Quality System, Design of Experiments, Program Management, Product Design, ISO, Continuous Improvement, SPC, Root Cause Analysis, Quality Assurance, GMP, Validation, ISO 13485, Design Control, CAPA, V&V, GD&T, FDA, Minitab, 5S, Process Simulation, Lean Manufacturing, Lean manufacturing, Medical Devices, Engineering, Leadership, Management, DMAIC, ISO 9000, Quality Management
Education
Universidad Regional del Norte 2002 — 2005
MBA, Operations Management
Universidad Autonoma de Zacatecas 1992 — 1997
Mechanical Engineer, Design
Jaime A Restrepo Jaime A Restrepo's Bioteknica Experience October 2011 - Present
Job Quality Engineer at BioTeknica
Industry Mechanical or Industrial Engineering
Experience
BioTeknica October 2011 - Present
Boston Scientific August 2011 - October 2011
Boston Scientific November 2010 - August 2011
Herratec SA September 2007 - May 2009
Beckman Coulter June 2005 - September 2007
Cordis, a Johnson & Johnson Company June 2002 - May 2004
Boston Scientific Inc September 2001 - August 2002
Bausch & Lomb January 1999 - September 2001
Skills
Design of Experiments, Quality Auditing, Continuous Improvement, FMEA, Design for Manufacturing, GD&T, Kaizen, SPC, Mechanical Engineering
Education
University of Miami 1996 — 1998
BSME, Mechanical Engineering
Miami Dade College 1991 — 1995
Associate of Arts (A.A.), Mechanical Engineering
BioTeknica October 2011 - Present
Boston Scientific August 2011 - October 2011
Boston Scientific November 2010 - August 2011
Herratec SA September 2007 - May 2009
Beckman Coulter June 2005 - September 2007
Cordis, a Johnson & Johnson Company June 2002 - May 2004
Boston Scientific Inc September 2001 - August 2002
Bausch & Lomb January 1999 - September 2001
Skills
Design of Experiments, Quality Auditing, Continuous Improvement, FMEA, Design for Manufacturing, GD&T, Kaizen, SPC, Mechanical Engineering
Education
University of Miami 1996 — 1998
BSME, Mechanical Engineering
Miami Dade College 1991 — 1995
Associate of Arts (A.A.), Mechanical Engineering
Scott Filion's Bioteknica Experience September 2006 - August 2009
Job Sr. Systems Engineer
Industry Medical Devices
Experience
Opti Medical Systems April 2014 - Present
Independent Contractor June 2013 - March 2014
Is International Services February 2012 - June 2013
Boston Scientific August 2009 - September 2011
BioTeknica September 2006 - August 2009
Novoste Corporation April 2001 - February 2005
Mallinckrodt August 1999 - April 2001
Mallinckrodt December 1997 - July 1999
Garmin International January 1996 - November 1997
Skills
Medical Devices, Medical Device..., Process Validation, Product Transfer, Electronics Assembly, Manufacturing Test, PFMEA, Electrostatic Discharge..., Instrumentation..., 21 CFR Part 11, 21 CFR 820, V&V, Validation, Manufacturing, Troubleshooting, Lean Manufacturing, R&D, FDA, Technical Writing, Technical Documentation, Quality Assurance, Root Cause Analysis, Continuous Improvement, Design of Experiments, ISO 13485, Risk Analysis, CAPA Resolution, CAPA, FMEA / PFMEA, Sop
Education
University of Kansas 1990 — 1995
BSEE, Electrical Engineering, 3.67 GPA
Opti Medical Systems April 2014 - Present
Independent Contractor June 2013 - March 2014
Is International Services February 2012 - June 2013
Boston Scientific August 2009 - September 2011
BioTeknica September 2006 - August 2009
Novoste Corporation April 2001 - February 2005
Mallinckrodt August 1999 - April 2001
Mallinckrodt December 1997 - July 1999
Garmin International January 1996 - November 1997
Skills
Medical Devices, Medical Device..., Process Validation, Product Transfer, Electronics Assembly, Manufacturing Test, PFMEA, Electrostatic Discharge..., Instrumentation..., 21 CFR Part 11, 21 CFR 820, V&V, Validation, Manufacturing, Troubleshooting, Lean Manufacturing, R&D, FDA, Technical Writing, Technical Documentation, Quality Assurance, Root Cause Analysis, Continuous Improvement, Design of Experiments, ISO 13485, Risk Analysis, CAPA Resolution, CAPA, FMEA / PFMEA, Sop
Education
University of Kansas 1990 — 1995
BSEE, Electrical Engineering, 3.67 GPA
Hugo Lagomasino's Bioteknica Experience 2001 - 2004
Job at Alcon
Industry Medical Devices
Experience
Alcon, a Novartis company September 2009 - Present
CIBA Vision May 2009 - September 2009
Ciba Vision Corp October 2006 - May 2009
Barry-Wehmiller Design Group 2004 - 2006
BioTeknica 2001 - 2004
Cordis 1998 - 2000
Noramco, Inc. 1983 - 1998
Skills
Validation, Manufacturing, GMP, FDA, CAPA, Change Control, V&V, Quality System, ISO 13485, Medical Devices, GxP, Computer System..., Pharmaceutical Industry, Sop, 21 CFR Part 11, Technology Transfer
Education
Brenau University
MBA, General Business
University of South Florida
BS, Chemical Engineering
Alcon, a Novartis company September 2009 - Present
CIBA Vision May 2009 - September 2009
Ciba Vision Corp October 2006 - May 2009
Barry-Wehmiller Design Group 2004 - 2006
BioTeknica 2001 - 2004
Cordis 1998 - 2000
Noramco, Inc. 1983 - 1998
Skills
Validation, Manufacturing, GMP, FDA, CAPA, Change Control, V&V, Quality System, ISO 13485, Medical Devices, GxP, Computer System..., Pharmaceutical Industry, Sop, 21 CFR Part 11, Technology Transfer
Education
Brenau University
MBA, General Business
University of South Florida
BS, Chemical Engineering
Andrew Vouloukos's Bioteknica Experience January 2008 - Present
Job Senior Quality Engineer at BioTeknica
Industry Electrical/Electronic Manufacturing
Experience
BioTeknica January 2008 - Present
Cordis 2000 - 2007
BD 1999 - 2000
Iomega Corporation 1997 - 1999
The Panda Project 1994 - 1995
Telectronics Pacing Systems 1992 - 1994
Self-Employed Contractor 1991 - 1992
IBM 1976 - 1991
IBM 1964 - 1976
Skills
Manufacturing, Electronics, Six Sigma, Microsoft Office, Product Development, Customer Service, Engineering, Project Management, Design of Experiments, Quality Assurance, SPC, Continuous Improvement
Education
Union College 1959 — 1964
Bachelor of Science, Electrical Engineering, Psychology
BioTeknica January 2008 - Present
Cordis 2000 - 2007
BD 1999 - 2000
Iomega Corporation 1997 - 1999
The Panda Project 1994 - 1995
Telectronics Pacing Systems 1992 - 1994
Self-Employed Contractor 1991 - 1992
IBM 1976 - 1991
IBM 1964 - 1976
Skills
Manufacturing, Electronics, Six Sigma, Microsoft Office, Product Development, Customer Service, Engineering, Project Management, Design of Experiments, Quality Assurance, SPC, Continuous Improvement
Education
Union College 1959 — 1964
Bachelor of Science, Electrical Engineering, Psychology
Jesus A. Gonzalez's Bioteknica Experience September 2011 - Present
Job Manufacturing Engineering Consultant
Industry Medical Devices
Experience
BioTeknica September 2011 - Present
OceanTrust Mortgage Corp. September 1991 - 2010
BAXTER DIAGNOSTICS, INCORPORATED. Miami, Florida. 1989 - 1991
DADE DIAGNOSTICS, INC. Miami, Florida. 1980 - 1989
Skills
Personal Finance, Process Improvement, Cross-functional Team..., Leadership, Product Management, Business Development, Start-ups, Strategic Planning, Budgets, Management, Quality Assurance, Business Strategy, Product Development, Sales, Manufacturing, Credit, Customer Service
Education
US Coast Guard 2010 — 2011
USCG Captains and Masters License, Captains and 50 ton Masters
Florida International University 1982 — 1983
Professional Certificate, Production and Manufacturing
Florida International University 1979 — 1983
BS, Industrial Technologies
BioTeknica September 2011 - Present
OceanTrust Mortgage Corp. September 1991 - 2010
BAXTER DIAGNOSTICS, INCORPORATED. Miami, Florida. 1989 - 1991
DADE DIAGNOSTICS, INC. Miami, Florida. 1980 - 1989
Skills
Personal Finance, Process Improvement, Cross-functional Team..., Leadership, Product Management, Business Development, Start-ups, Strategic Planning, Budgets, Management, Quality Assurance, Business Strategy, Product Development, Sales, Manufacturing, Credit, Customer Service
Education
US Coast Guard 2010 — 2011
USCG Captains and Masters License, Captains and 50 ton Masters
Florida International University 1982 — 1983
Professional Certificate, Production and Manufacturing
Florida International University 1979 — 1983
BS, Industrial Technologies
Ebony (Daniels) Sanon's Bioteknica Experience January 2015 - Present
Job Business Development Manager and Quality Engineer at BioTeknica
Industry Medical Devices
Experience
BioTeknica January 2015 - Present
BioTeknica October 2012 - Present
FDA May 2012 - September 2012
Goode Consulting International May 2011 - May 2012
Florida International University June 2010 - May 2011
NASA Goddard Space Flight Center May 2009 - August 2009
Texas Instruments 2001 - 2002
Skills
Electrochemical..., X-Ray Diffraction, Cell Culture, Matlab, Contact Angle Meter, Medical Devices, Impedance Spectroscopy, Biomedical Engineering, Validation
Education
Florida International University 2008 — 2012
Master of Science, Biomedical Engineering
Howard University 1996 — 2001
Bachelor of Science, Mechanical Engineering
BioTeknica January 2015 - Present
BioTeknica October 2012 - Present
FDA May 2012 - September 2012
Goode Consulting International May 2011 - May 2012
Florida International University June 2010 - May 2011
NASA Goddard Space Flight Center May 2009 - August 2009
Texas Instruments 2001 - 2002
Skills
Electrochemical..., X-Ray Diffraction, Cell Culture, Matlab, Contact Angle Meter, Medical Devices, Impedance Spectroscopy, Biomedical Engineering, Validation
Education
Florida International University 2008 — 2012
Master of Science, Biomedical Engineering
Howard University 1996 — 2001
Bachelor of Science, Mechanical Engineering
Naveen Kancharla's Bioteknica Experience February 2005 - September 2013
Job Sr. Controls Engineer at Aveva Drug Delivery Systems
Industry Pharmaceuticals
Experience
Aveva Drug Delivery Systems September 2013 - Present
Bioteknica February 2005 - September 2013
Skills
PLC, Automation, Electrical Engineering, SCADA, Control Systems Design, Commissioning, Project Engineering, Allen Bradley, Validation, DCS, Electronics, Labview, Engineering Management, Robotics, Lean Manufacturing, Root Cause Analysis, R&D
Education
University of South Florida 2001 — 2003
Masters, Electrical engineering
Aveva Drug Delivery Systems September 2013 - Present
Bioteknica February 2005 - September 2013
Skills
PLC, Automation, Electrical Engineering, SCADA, Control Systems Design, Commissioning, Project Engineering, Allen Bradley, Validation, DCS, Electronics, Labview, Engineering Management, Robotics, Lean Manufacturing, Root Cause Analysis, R&D
Education
University of South Florida 2001 — 2003
Masters, Electrical engineering
Doug Weitzel's Bioteknica Experience 2005 - 2011
Job Quality Professional at Weitzel & Associates
Industry Medical Devices
Experience
Weitzel & Associates Validation ConsultantADC2010 - 2011
BioTeknica 2005 - 2011
Physio 2008 - 2010
Edwards Lifesciences 2007 - 2008
Abbott Laboratories 1989 - 2005
Abbott Laboratories 1989 - 2005
Skills
CAPA, ISO 13485, 21 CFR Part 11, V&V, FDA, Change Control, Quality System, Validation, GMP, ISO 14971, Design Control, Medical Devices, Quality Auditing, GxP, Sop, CQA, Computer System..., Supplier Quality, DMAIC, Root Cause Analysis
Education
Cornell University 1984 — 1986
Bachelor of Science (BS), Mechanical Engineering
Ithaca College 1981 — 1984
Bachelor's degree, Physics
Weitzel & Associates Validation ConsultantADC2010 - 2011
BioTeknica 2005 - 2011
Physio 2008 - 2010
Edwards Lifesciences 2007 - 2008
Abbott Laboratories 1989 - 2005
Abbott Laboratories 1989 - 2005
Skills
CAPA, ISO 13485, 21 CFR Part 11, V&V, FDA, Change Control, Quality System, Validation, GMP, ISO 14971, Design Control, Medical Devices, Quality Auditing, GxP, Sop, CQA, Computer System..., Supplier Quality, DMAIC, Root Cause Analysis
Education
Cornell University 1984 — 1986
Bachelor of Science (BS), Mechanical Engineering
Ithaca College 1981 — 1984
Bachelor's degree, Physics
Jose A. Rodriguez's Bioteknica Experience January 2011 - April 2011
Job Principal / Director of Operations at BioPharma Regulatory Solutions Inc
Industry Pharmaceuticals
Experience
Qualitest Pharmaceuticals November 2014 - Present
BioPharma Regulatory Solutions, Inc. January 2010 - Present
Q Pharma May 2011 - August 2014
Novartis 2014 - 2014
Novartis 2014 - 2014
Novartis 2014 - 2014
Novartis 2013 - 2014
CorePharma LLC 2011 - 2013
Bioteknica January 2011 - April 2011
RCS 2010 - 2010
Skills
Validation, FDA, Medical Devices, Manufacturing, Engineering, Process Validation, cGMP, 21 CFR Part 11, Computer System..., Pharmaceuticals, Change Control, CAPA, GLP, Quality Systems, Regulatory Affairs, GCP, GxP, Technology Transfer, Quality Auditing, Aseptic Processing, Quality Assurance, Cleaning Validation, ISO 13485, Protocol Development, Life Sciences, Quality Management, Software Validation, GMP, Pharmaceutical Industry, Quality System, Pharmaceutics, R&D, Software Documentation, GAMP, Quality Control, Sop, Biopharmaceuticals, Member ISPE & ASQ, Regulatory Submissions, LIMS, Regulatory Requirements, V&V, Drug Development, Process Simulation, SOP, Process Improvement, Biotechnology, Cross-functional Team..., Management, Project Management
Education
Florida International University 2013 — 2015
Master of Business Administration (MBA), Project Management
InterAmerican University of PR 1992 — 1998
BS, Natural Sciences - major in Health Sciences and minor in Pharmaceutical Sciences, BS Organic Chemistry
Qualitest Pharmaceuticals November 2014 - Present
BioPharma Regulatory Solutions, Inc. January 2010 - Present
Q Pharma May 2011 - August 2014
Novartis 2014 - 2014
Novartis 2014 - 2014
Novartis 2014 - 2014
Novartis 2013 - 2014
CorePharma LLC 2011 - 2013
Bioteknica January 2011 - April 2011
RCS 2010 - 2010
Skills
Validation, FDA, Medical Devices, Manufacturing, Engineering, Process Validation, cGMP, 21 CFR Part 11, Computer System..., Pharmaceuticals, Change Control, CAPA, GLP, Quality Systems, Regulatory Affairs, GCP, GxP, Technology Transfer, Quality Auditing, Aseptic Processing, Quality Assurance, Cleaning Validation, ISO 13485, Protocol Development, Life Sciences, Quality Management, Software Validation, GMP, Pharmaceutical Industry, Quality System, Pharmaceutics, R&D, Software Documentation, GAMP, Quality Control, Sop, Biopharmaceuticals, Member ISPE & ASQ, Regulatory Submissions, LIMS, Regulatory Requirements, V&V, Drug Development, Process Simulation, SOP, Process Improvement, Biotechnology, Cross-functional Team..., Management, Project Management
Education
Florida International University 2013 — 2015
Master of Business Administration (MBA), Project Management
InterAmerican University of PR 1992 — 1998
BS, Natural Sciences - major in Health Sciences and minor in Pharmaceutical Sciences, BS Organic Chemistry
Parisa Baniasad's Bioteknica Experience 2013 - Present
Job Quality Engineer at BioTeknica
Industry Medical Devices
Experience
BioTeknica 2013 - Present
Skills
Microsoft Office, Research, Leadership, Microsoft Excel, Microsoft Word, PowerPoint, Sales, Training, Medical Devices, FDA, Test Method Validation, Management, Validation, R&D, Chemistry, Engineering, Laboratory, Biochemistry, Continuous Improvement, ELISA, Manufacturing, Microbiology, Quality Assurance, Quality System, Science, Six Sigma
Education
KTH Royal Institute of Technology 1997 — 2001
Master's degree, Biomedical/Medical Engineering
Karolinska institutet
Bachelor's Degree, Biomedical Laboratory Science
Mashhad University of Medical Sciences
Associate's Degree, Medical Lab Sciences
BioTeknica 2013 - Present
Skills
Microsoft Office, Research, Leadership, Microsoft Excel, Microsoft Word, PowerPoint, Sales, Training, Medical Devices, FDA, Test Method Validation, Management, Validation, R&D, Chemistry, Engineering, Laboratory, Biochemistry, Continuous Improvement, ELISA, Manufacturing, Microbiology, Quality Assurance, Quality System, Science, Six Sigma
Education
KTH Royal Institute of Technology 1997 — 2001
Master's degree, Biomedical/Medical Engineering
Karolinska institutet
Bachelor's Degree, Biomedical Laboratory Science
Mashhad University of Medical Sciences
Associate's Degree, Medical Lab Sciences
Eugene Wu's Bioteknica Experience Sr. Software Quality ConsultantQualified Data Systems2003 - Present
Job Principal Engineer / Senior Quality Consultant at BioTeknica
Industry Medical Devices
Experience
BioTeknica Sr. Software Quality ConsultantQualified Data Systems2003 - Present
Philips DXR Hamburg 2010 - 2011
Philips Healthcare 2010 - 2011
Guidant 2003 - 2006
Education
The University of Texas at Dallas 1999 — 2001
Master's Degree, Computer Software Engineering
Clemson University 1987 — 1991
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
National Taiwan University 1978 — 1983
Bachelor's Degree, Veterinary Medicine
BioTeknica Sr. Software Quality ConsultantQualified Data Systems2003 - Present
Philips DXR Hamburg 2010 - 2011
Philips Healthcare 2010 - 2011
Guidant 2003 - 2006
Education
The University of Texas at Dallas 1999 — 2001
Master's Degree, Computer Software Engineering
Clemson University 1987 — 1991
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
National Taiwan University 1978 — 1983
Bachelor's Degree, Veterinary Medicine
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