Holaira, Inc.
Description
Address: 3750 Annapolis Ln N #105, Plymouth, MN 55447 Phone: (763) 450-2800Category: Website: : : Place name: : Hours: : : : Website: https://www.nuvaira.com/ Category: Corporate office Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo.Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Nuvaira Inc. Posting publicly on the Web Write a review Reviews Be the first to review
Holaira, Inc. List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Holaira, Inc.. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Holaira, Inc. Employees
Employee
Years
Job
Industry
Shayla Farmer Shayla Farmer's Holaira, Inc. Experience September 2015 - Present
Job Senior Accountant at Holaira, Inc.
Industry Retail
Experience
Holaira, Inc. September 2015 - Present
CC & Mays June 2013 - Present
Aimia Inc February 2013 - June 2013
Virtual Radiologic September 2012 - February 2013
Virtual Radiologic May 2012 - September 2012
Virtual Radiologic June 2009 - July 2011
Skills
Great Plains Software, Account Reconciliation, Financial Statements, General Ledger, Accounting, Sarbanes-Oxley, Financial Reporting, ADP Payroll, Financial Analysis, Accruals, Financial Accounting, Variance Analysis, Epicor, Fixed Assets, Journal Entries, US GAAP, iVantage, Cash Flow Forecasting, Retail Buying, Visual Merchandising, Merchandise Planning, Owner-managed businesses, Retail Sales, Retail Sales Analysis, Retail Audit, Childrenswear, Kidswear
Education
University of St. Thomas 2012 — 2012
Mini-Masters Financial Management, Accounting and Finance
University of Phoenix 2006 — 2009
BS Accounting, Accounting
Holaira, Inc. September 2015 - Present
CC & Mays June 2013 - Present
Aimia Inc February 2013 - June 2013
Virtual Radiologic September 2012 - February 2013
Virtual Radiologic May 2012 - September 2012
Virtual Radiologic June 2009 - July 2011
Skills
Great Plains Software, Account Reconciliation, Financial Statements, General Ledger, Accounting, Sarbanes-Oxley, Financial Reporting, ADP Payroll, Financial Analysis, Accruals, Financial Accounting, Variance Analysis, Epicor, Fixed Assets, Journal Entries, US GAAP, iVantage, Cash Flow Forecasting, Retail Buying, Visual Merchandising, Merchandise Planning, Owner-managed businesses, Retail Sales, Retail Sales Analysis, Retail Audit, Childrenswear, Kidswear
Education
University of St. Thomas 2012 — 2012
Mini-Masters Financial Management, Accounting and Finance
University of Phoenix 2006 — 2009
BS Accounting, Accounting
Alissa Bergman, CPA Alissa Bergman, CPA's Holaira, Inc. Experience September 2013 - Present
Job Controller
Industry Accounting
Experience
Holaira, Inc. September 2013 - Present
Virtual Radiologic December 2007 - August 2013
First Capital Commercial Services June 2007 - December 2007
Wipfli LLP November 2005 - June 2007
Seim Johnson, LLP June 2003 - November 2005
McGladrey January 2003 - April 2003
Skills
Account Reconciliation, Accounting, Auditing, CPA, Financial Accounting, Financial Statements, General Ledger, Great Plains Software, Healthcare, Internal Controls, Microsoft Excel, Process Improvement, Tax, Financial Analysis, Financial Reporting, Sarbanes-Oxley
Education
Minnesota State University, Moorhead 1998 — 2002
Bachelor of Science, Accounting
Holaira, Inc. September 2013 - Present
Virtual Radiologic December 2007 - August 2013
First Capital Commercial Services June 2007 - December 2007
Wipfli LLP November 2005 - June 2007
Seim Johnson, LLP June 2003 - November 2005
McGladrey January 2003 - April 2003
Skills
Account Reconciliation, Accounting, Auditing, CPA, Financial Accounting, Financial Statements, General Ledger, Great Plains Software, Healthcare, Internal Controls, Microsoft Excel, Process Improvement, Tax, Financial Analysis, Financial Reporting, Sarbanes-Oxley
Education
Minnesota State University, Moorhead 1998 — 2002
Bachelor of Science, Accounting
Steve Mertens Steve Mertens's Holaira, Inc. Experience November 2012 - Present
Job Executive/business leader with a history of developing market leading products
Industry Medical Devices
Experience
Holaira, Inc. November 2012 - Present
Boston Scientific February 2010 - November 2012
Boston Scientific January 2005 - February 2010
Boston Scientific 2001 - 2005
Boston Scientific 1999 - 2001
Boston Scientific January 1995 - January 1999
Scimed Life Systems January 1993 - January 1995
Scimed Lifesystems January 1991 - January 1993
HTI January 1989 - January 1991
HTI January 1985 - January 1989
Skills
Product Development, Technology Development, Organizational..., Research, Process Engineering, Program Management, Portfolio Management, Technology Evaluation, Medical Devices, Quality System, Drug Delivery, Design of Experiments, Biomedical Engineering, FDA, ISO 13485, Product Launch, Biotechnology, Lifesciences, Patents, Cross-functional Team..., Cardiology, R&D, Leadership, Process Simulation, Pharmaceutical Industry, Technology Transfer, Catheters, Validation, CAPA, V&V, Design Control, GMP, Clinical Trials, Market Development, Clinical Development, Regulatory Affairs, Polymers, Hardware Diagnostics, DMAIC, Product Design, Quality Control, FMEA, Technology Integration, Strategic Planning, Strategic Partnerships, Technology Management, Life Sciences, Commercialization, Manufacturing, Management
Education
University of St. Thomas - Opus College of Business 1992 — 1998
Master, Business Administration
University of Minnesota-Twin Cities 1981 — 1985
Bachelors, Chemical engineering
Holaira, Inc. November 2012 - Present
Boston Scientific February 2010 - November 2012
Boston Scientific January 2005 - February 2010
Boston Scientific 2001 - 2005
Boston Scientific 1999 - 2001
Boston Scientific January 1995 - January 1999
Scimed Life Systems January 1993 - January 1995
Scimed Lifesystems January 1991 - January 1993
HTI January 1989 - January 1991
HTI January 1985 - January 1989
Skills
Product Development, Technology Development, Organizational..., Research, Process Engineering, Program Management, Portfolio Management, Technology Evaluation, Medical Devices, Quality System, Drug Delivery, Design of Experiments, Biomedical Engineering, FDA, ISO 13485, Product Launch, Biotechnology, Lifesciences, Patents, Cross-functional Team..., Cardiology, R&D, Leadership, Process Simulation, Pharmaceutical Industry, Technology Transfer, Catheters, Validation, CAPA, V&V, Design Control, GMP, Clinical Trials, Market Development, Clinical Development, Regulatory Affairs, Polymers, Hardware Diagnostics, DMAIC, Product Design, Quality Control, FMEA, Technology Integration, Strategic Planning, Strategic Partnerships, Technology Management, Life Sciences, Commercialization, Manufacturing, Management
Education
University of St. Thomas - Opus College of Business 1992 — 1998
Master, Business Administration
University of Minnesota-Twin Cities 1981 — 1985
Bachelors, Chemical engineering
Eliud Gikaru ,CQE Eliud Gikaru ,CQE's Holaira, Inc. Experience February 2015 - Present
Job Quality Engineer
Industry Medical Devices
Experience
Holaira, Inc. February 2015 - Present
Boston Scientific March 2012 - February 2015
Arizant Healthcare February 2010 - April 2012
ev3 inc March 2006 - February 2010
Skills
Quality System, SPC, Gage G&R, Lean Manufacturing, Design of Experiments, CAPA, FMEA, Quality Assurance, Continuous Improvement, Root Cause Analysis, Materials, Testing, Validation, Manufacturing, GMP, ISO 13485
Education
Saint Mary's University of Minnesota 2006 — 2008
MS, Project Management
University of Nairobi
Bachelor of science, Engineering
Holaira, Inc. February 2015 - Present
Boston Scientific March 2012 - February 2015
Arizant Healthcare February 2010 - April 2012
ev3 inc March 2006 - February 2010
Skills
Quality System, SPC, Gage G&R, Lean Manufacturing, Design of Experiments, CAPA, FMEA, Quality Assurance, Continuous Improvement, Root Cause Analysis, Materials, Testing, Validation, Manufacturing, GMP, ISO 13485
Education
Saint Mary's University of Minnesota 2006 — 2008
MS, Project Management
University of Nairobi
Bachelor of science, Engineering
Jim Pavliska Jim Pavliska's Holaira, Inc. Experience January 2013 - Present
Job VP Clinical Affairs at Holaira, Inc.
Industry Research
Experience
Holaira, Inc. January 2013 - Present
Consultant September 2012 - January 2013
CR Bard June 2008 - September 2012
St. Jude Medical 2001 - 2008
St. Jude Medical 2005 - 2007
Velocimed, LLC 2001 - 2006
Medtronic 1998 - 2001
Partners Healthcare 1996 - 1998
Skills
Clinical, Clinical Trials, Clinical Research, Medical Devices, Clinical Development, FDA, Research, Healthcare, Cardiology, Interventional Radiology, Hospitals, ISO 13485, Orthopedic, Cross-functional Team..., Life Sciences, Biomedical Engineering, Medicine, Lifesciences, Biotechnology
Education
Texas A&M University 1992 — 1996
BS, Biomedical Science
Holaira, Inc. January 2013 - Present
Consultant September 2012 - January 2013
CR Bard June 2008 - September 2012
St. Jude Medical 2001 - 2008
St. Jude Medical 2005 - 2007
Velocimed, LLC 2001 - 2006
Medtronic 1998 - 2001
Partners Healthcare 1996 - 1998
Skills
Clinical, Clinical Trials, Clinical Research, Medical Devices, Clinical Development, FDA, Research, Healthcare, Cardiology, Interventional Radiology, Hospitals, ISO 13485, Orthopedic, Cross-functional Team..., Life Sciences, Biomedical Engineering, Medicine, Lifesciences, Biotechnology
Education
Texas A&M University 1992 — 1996
BS, Biomedical Science
Dennis Wahr M.D. Dennis Wahr M.D.'s Holaira, Inc. Experience September 2012 - Present
Job CEO at Holaira
Industry Medical Devices
Experience
Holaira, Inc. September 2012 - Present
Lutonix July 2007 - December 2011
Velocimed January 2001 - July 2005
Skills
Commercialization, Management, Medical Devices, Product Development, Product Launch, Start-ups, Biotechnology, Clinical Trials, Cross-functional Team..., Entrepreneurship, FDA, Market Development, Mergers, Strategic Planning, Venture Capital
Education
Albion College
University of California San Francisco
Cardiology Fellowship
Holaira, Inc. September 2012 - Present
Lutonix July 2007 - December 2011
Velocimed January 2001 - July 2005
Skills
Commercialization, Management, Medical Devices, Product Development, Product Launch, Start-ups, Biotechnology, Clinical Trials, Cross-functional Team..., Entrepreneurship, FDA, Market Development, Mergers, Strategic Planning, Venture Capital
Education
Albion College
University of California San Francisco
Cardiology Fellowship
Holly Lee's Holaira, Inc. Experience December 2014 - Present
Job Sr. Clinical Study Manager
Industry Medical Devices
Experience
Holaira, Inc. December 2014 - Present
St. Jude Medical September 2014 - December 2014
St. Jude Medical February 2012 - September 2014
Uroplasty, Inc May 2008 - February 2012
MedNet Solutions March 2007 - May 2008
Park Nicollet Health Services June 2004 - February 2007
Skills
Clinical, Oncology, Urology, Clinical Trial..., Medical Devices, Clinical Trials, Clinical Research, Clinical Monitoring, GCP, CTMS, EDC, ICH-GCP, Regulatory Affairs, Cardiology, Clinical Data Management, ISO 13485, FDA, CAPA
Education
University of Minnesota-Twin Cities 1999 — 2004
BS, Nutritional Science
Holaira, Inc. December 2014 - Present
St. Jude Medical September 2014 - December 2014
St. Jude Medical February 2012 - September 2014
Uroplasty, Inc May 2008 - February 2012
MedNet Solutions March 2007 - May 2008
Park Nicollet Health Services June 2004 - February 2007
Skills
Clinical, Oncology, Urology, Clinical Trial..., Medical Devices, Clinical Trials, Clinical Research, Clinical Monitoring, GCP, CTMS, EDC, ICH-GCP, Regulatory Affairs, Cardiology, Clinical Data Management, ISO 13485, FDA, CAPA
Education
University of Minnesota-Twin Cities 1999 — 2004
BS, Nutritional Science
Linda Freemon's Holaira, Inc. Experience December 2014 - August 2015
Job Materials Planner at Holaira, Inc.
Industry Biotechnology
Experience
Holaira, Inc. December 2014 - August 2015
Medtronic Inc June 2011 - November 2014
ev3/Covidien January 2011 - June 2011
ev3 January 2010 - June 2011
ev3 January 2008 - June 2011
Acist Medical Systems 2006 - 2008
Vascular Solutions, Inc. 2000 - 2006
fargo electronics 1993 - 2000
Formerly called Medical Devices, Inc 1992 - 1993
Honeywell/Alliant Techsystems 1987 - 1991
Skills
Medical Devices, Continuous Improvement, Manufacturing, Six Sigma, Supply Chain Management, ISO 13485, Strategic Sourcing, MRP, Product Development, Procurement, Sourcing, Inventory Management, Purchasing, Leadership, Lean Manufacturing, R&D, Management, Quality System, Operations Management, Supplier Quality, Engineering, Program Management, Negotiation, Cross-functional Team..., FDA, Process Improvement, Global Sourcing, Supply Chain, Supply Management, ISO, Product Launch, Design of Experiments, DMAIC
Education
St. Catherine University 1986 — 1989
BA, Communication
Holaira, Inc. December 2014 - August 2015
Medtronic Inc June 2011 - November 2014
ev3/Covidien January 2011 - June 2011
ev3 January 2010 - June 2011
ev3 January 2008 - June 2011
Acist Medical Systems 2006 - 2008
Vascular Solutions, Inc. 2000 - 2006
fargo electronics 1993 - 2000
Formerly called Medical Devices, Inc 1992 - 1993
Honeywell/Alliant Techsystems 1987 - 1991
Skills
Medical Devices, Continuous Improvement, Manufacturing, Six Sigma, Supply Chain Management, ISO 13485, Strategic Sourcing, MRP, Product Development, Procurement, Sourcing, Inventory Management, Purchasing, Leadership, Lean Manufacturing, R&D, Management, Quality System, Operations Management, Supplier Quality, Engineering, Program Management, Negotiation, Cross-functional Team..., FDA, Process Improvement, Global Sourcing, Supply Chain, Supply Management, ISO, Product Launch, Design of Experiments, DMAIC
Education
St. Catherine University 1986 — 1989
BA, Communication
Danielle Forstner Danielle Forstner's Holaira, Inc. Experience August 2014 - Present
Job Clinical Data Manager at Holaira
Industry Research
Experience
Holaira, Inc. August 2014 - Present
Holaira April 2013 - August 2014
St. Jude Medical February 2013 - April 2013
Sorin Group October 2011 - January 2013
Mayo Clinic Health System Mankato May 2008 - April 2011
Nova Academy of Cosmetology November 2007 - May 2008
River's Edge Hospital October 2006 - September 2007
Skills
Clinical Research, CTMS, FDA, Medical Devices, Clinical Trials, Clinical Trial Database..., Biotechnology, Cardiology, Clinical Development, EDC, GCP, Leadership, Lifesciences, Management, Protocol, Regulatory Affairs, Regulatory Submissions, Training
Education
Gustavus Adolphus College 2004 — 2007
B.A., Biology
LifeScience Alley
Holaira, Inc. August 2014 - Present
Holaira April 2013 - August 2014
St. Jude Medical February 2013 - April 2013
Sorin Group October 2011 - January 2013
Mayo Clinic Health System Mankato May 2008 - April 2011
Nova Academy of Cosmetology November 2007 - May 2008
River's Edge Hospital October 2006 - September 2007
Skills
Clinical Research, CTMS, FDA, Medical Devices, Clinical Trials, Clinical Trial Database..., Biotechnology, Cardiology, Clinical Development, EDC, GCP, Leadership, Lifesciences, Management, Protocol, Regulatory Affairs, Regulatory Submissions, Training
Education
Gustavus Adolphus College 2004 — 2007
B.A., Biology
LifeScience Alley
Terry Irwin, MBA, CMQ/OE's Holaira, Inc. Experience April 2013 - Present
Job Medical Device and Quality Professional
Industry Medical Devices
Experience
Holaira, Inc. April 2013 - Present
Boston Scientific January 2007 - November 2012
Boston Scientific February 2004 - January 2007
New York Life Insurance Company July 2003 - January 2004
CIVCO Medical Solutions January 2000 - July 2003
CIVCO Medical Solutions October 1996 - January 2000
Parametric Technology Corporation July 1995 - October 1996
Computer Aided Design Software, Inc. May 1992 - July 1995
Skills
FDA Regulatory..., Equipment IQ/OQ/PQ, Software Validation, ISO 14001, ISO 13485, ISO 9001, EN 46001, Medical Devices, Standards Compliance, Quality Auditing, Product Design and..., Statistics, Design of Experiments, Lean Sigma, Green Belt, Value Stream Mapping, Quality Management, Quality by Design, CAD/CAM/CAE, Risk Management, Organizational..., Organizational..., Sterilization..., Test Methodologies, Test Planning, User Acceptance Testing, Data Analysis, Budget Management, Capital Budgeting, Equipment Design, Supplier Quality and..., Project Planning and..., Direct Sales, MBA, Mechanical Engineering, Calibration and..., Regulatory Submissions, Strategic Planning, SWOT analysis, FMEA, Quality Assurance and..., Clean Room Validation, Construction, Measurement System..., Finite Element Analysis, Software Sales, 21 CFR, Six Sigma, FDA, Validation
Education
University of Saint Thomas - School of Business 2005 — 2008
MBA, Business
University of Iowa 1988 — 1992
Bachelor of Science, Mechanical Engineering
Holaira, Inc. April 2013 - Present
Boston Scientific January 2007 - November 2012
Boston Scientific February 2004 - January 2007
New York Life Insurance Company July 2003 - January 2004
CIVCO Medical Solutions January 2000 - July 2003
CIVCO Medical Solutions October 1996 - January 2000
Parametric Technology Corporation July 1995 - October 1996
Computer Aided Design Software, Inc. May 1992 - July 1995
Skills
FDA Regulatory..., Equipment IQ/OQ/PQ, Software Validation, ISO 14001, ISO 13485, ISO 9001, EN 46001, Medical Devices, Standards Compliance, Quality Auditing, Product Design and..., Statistics, Design of Experiments, Lean Sigma, Green Belt, Value Stream Mapping, Quality Management, Quality by Design, CAD/CAM/CAE, Risk Management, Organizational..., Organizational..., Sterilization..., Test Methodologies, Test Planning, User Acceptance Testing, Data Analysis, Budget Management, Capital Budgeting, Equipment Design, Supplier Quality and..., Project Planning and..., Direct Sales, MBA, Mechanical Engineering, Calibration and..., Regulatory Submissions, Strategic Planning, SWOT analysis, FMEA, Quality Assurance and..., Clean Room Validation, Construction, Measurement System..., Finite Element Analysis, Software Sales, 21 CFR, Six Sigma, FDA, Validation
Education
University of Saint Thomas - School of Business 2005 — 2008
MBA, Business
University of Iowa 1988 — 1992
Bachelor of Science, Mechanical Engineering
Dave Matson's Holaira, Inc. Experience January 2013 - Present
Job Director of Quality at Holaira, Inc.
Industry Medical Devices
Experience
Holaira, Inc. January 2013 - Present
EnteroMedics September 2012 - January 2013
Apnex Medical May 2008 - September 2012
Boston Scientific January 2005 - April 2008
CVRx, Inc 2002 - 2005
TERAMed, Inc. 1998 - 2002
Vascular Solutions 1997 - 1998
SciMed Life Systems 1991 - 1997
Skills
ISO 13485, Medical Devices, Design Control, ISO 14971, V&V, FDA, CAPA, Minitab, Validation, 21 CFR Part 11, Quality System, Design of Experiments, Manufacturing, Regulatory Submissions, Supplier Quality, FMEA, Product Development, R&D, Quality Control, Design for Manufacturing, Lifesciences, SPC, Cross-functional Team..., 21 CFR, Biomedical Engineering, Biotechnology, Quality Assurance
Education
University of Minnesota-Twin Cities
BS, Statistics
Holaira, Inc. January 2013 - Present
EnteroMedics September 2012 - January 2013
Apnex Medical May 2008 - September 2012
Boston Scientific January 2005 - April 2008
CVRx, Inc 2002 - 2005
TERAMed, Inc. 1998 - 2002
Vascular Solutions 1997 - 1998
SciMed Life Systems 1991 - 1997
Skills
ISO 13485, Medical Devices, Design Control, ISO 14971, V&V, FDA, CAPA, Minitab, Validation, 21 CFR Part 11, Quality System, Design of Experiments, Manufacturing, Regulatory Submissions, Supplier Quality, FMEA, Product Development, R&D, Quality Control, Design for Manufacturing, Lifesciences, SPC, Cross-functional Team..., 21 CFR, Biomedical Engineering, Biotechnology, Quality Assurance
Education
University of Minnesota-Twin Cities
BS, Statistics
Rick Gunderson's Holaira, Inc. Experience February 2013 - Present
Job Program Manager at Holaira, Inc.
Industry Medical Devices
Experience
Holaira, Inc. February 2013 - Present
Medical Device Consultant December 2012 - January 2013
Boston Scientific January 2002 - November 2012
IntraTherapeutics (now ev3/Covidien) 1998 - 2002
Medtronic May 1996 - April 1998
MedAmicus (now enpath Medical) May 1995 - May 1996
SpectraScience (GV Medical) March 1992 - May 1995
Skills
Medical Devices, Techincal Leadership, Design Control, R&D, Innovation, Commercialization, FDA, Biomedical Engineering, Product Development, Product Management, Technology Evaluation, Patents, Peripheral Vascular, Cardiovascular, Biodesign, Intellectual Property, Idea Generation, Prototyping, Cath Lab Knowledge, Prototype, Catheters, Drug Delivery, Stents, Failure Analysis, Biomaterials, Product Launch, CAPA, Design for Manufacturing, Validation, V&V, Minitab, DMAIC, Manufacturing, FMEA, SPC, Process Simulation, 21 CFR
Education
The University of North Dakota 1986 — 1990
BSME, Mechanical Engineering
Holaira, Inc. February 2013 - Present
Medical Device Consultant December 2012 - January 2013
Boston Scientific January 2002 - November 2012
IntraTherapeutics (now ev3/Covidien) 1998 - 2002
Medtronic May 1996 - April 1998
MedAmicus (now enpath Medical) May 1995 - May 1996
SpectraScience (GV Medical) March 1992 - May 1995
Skills
Medical Devices, Techincal Leadership, Design Control, R&D, Innovation, Commercialization, FDA, Biomedical Engineering, Product Development, Product Management, Technology Evaluation, Patents, Peripheral Vascular, Cardiovascular, Biodesign, Intellectual Property, Idea Generation, Prototyping, Cath Lab Knowledge, Prototype, Catheters, Drug Delivery, Stents, Failure Analysis, Biomaterials, Product Launch, CAPA, Design for Manufacturing, Validation, V&V, Minitab, DMAIC, Manufacturing, FMEA, SPC, Process Simulation, 21 CFR
Education
The University of North Dakota 1986 — 1990
BSME, Mechanical Engineering
Melissa Ulberg's Holaira, Inc. Experience January 2013 - Present
Job General Accountant at Holaira, Inc.
Industry Accounting
Experience
Holaira, Inc. January 2013 - Present
- May 2008 - December 2012
- January 2007 - May 2008
Velocimed, Inc. (St. Jude Medical) March 2004 - December 2006
ATK August 2001 - March 2004
Copeland Buhl & Company January 2000 - August 2001
Education
St. Cloud State University 1997 — 1999
BS Accounting
Holaira, Inc. January 2013 - Present
- May 2008 - December 2012
- January 2007 - May 2008
Velocimed, Inc. (St. Jude Medical) March 2004 - December 2006
ATK August 2001 - March 2004
Copeland Buhl & Company January 2000 - August 2001
Education
St. Cloud State University 1997 — 1999
BS Accounting
Joseph Ostendorf, RAC's Holaira, Inc. Experience July 2013 - Present
Job Regulatory Affairs Manager
Industry Medical Devices
Experience
Holaira, Inc. July 2013 - Present
Ostendorf Consulting May 2012 - July 2013
Waters October 2010 - May 2012
Biotronik August 2009 - June 2010
Zimmer August 2008 - August 2009
Boston Scientific July 2006 - August 2008
Boston Scientific January 2005 - June 2006
Boston Scientific May 2004 - August 2004
Skills
FDA, Regulatory Affairs, Design Control, Regulatory Submissions, PMA, ISO 13485, Medical Devices, CAPA, Validation, V&V, Quality System, GMP, Clinical Trials, Biotechnology, Biomedical Engineering, IVD, ISO 14971
Education
University of Minnesota-Twin Cities 2000 — 2004
BS, Scientific & Technical Communication
Saint John's University 1999 — 2000
Biology, Chemistry
Holaira, Inc. July 2013 - Present
Ostendorf Consulting May 2012 - July 2013
Waters October 2010 - May 2012
Biotronik August 2009 - June 2010
Zimmer August 2008 - August 2009
Boston Scientific July 2006 - August 2008
Boston Scientific January 2005 - June 2006
Boston Scientific May 2004 - August 2004
Skills
FDA, Regulatory Affairs, Design Control, Regulatory Submissions, PMA, ISO 13485, Medical Devices, CAPA, Validation, V&V, Quality System, GMP, Clinical Trials, Biotechnology, Biomedical Engineering, IVD, ISO 14971
Education
University of Minnesota-Twin Cities 2000 — 2004
BS, Scientific & Technical Communication
Saint John's University 1999 — 2000
Biology, Chemistry
Amy Wolter's Holaira, Inc. Experience 2013 - Present
Job Office Administrator, Holaira, Inc.
Industry Medical Devices
Experience
Holaira, Inc. 2013 - Present
Bank of America April 2010 - Present
Bank of America July 2009 - April 2010
Bank of America April 2009 - July 2009
State of Minnesota 2007 - 2009
State of Minnesota 2005 - 2007
Education
University of Minnesota, Morris 2001 — 2005
Bachelor of Arts, Political Science and Government
Holaira, Inc. 2013 - Present
Bank of America April 2010 - Present
Bank of America July 2009 - April 2010
Bank of America April 2009 - July 2009
State of Minnesota 2007 - 2009
State of Minnesota 2005 - 2007
Education
University of Minnesota, Morris 2001 — 2005
Bachelor of Arts, Political Science and Government
Mahtab Fatemi's Holaira, Inc. Experience March 2015 - Present
Job VP Regulatory Affairs at Holaira, Inc.
Industry Biotechnology
Experience
Holaira, Inc. March 2015 - Present
Holaira, Inc December 2012 - Present
Sole Proprietor June 2008 - January 2013
MAP Pharmaceuticals January 2006 - May 2008
BD Biosciences 1999 - 2006
Roche 1995 - 1996
Roche 1995 - 1996
Skills
Lifesciences, Clinical Trials, FDA, Biotechnology, Regulatory Affairs, Medical Devices, Licensing, ISO 13485, Pharmaceutical Industry, Technology Transfer, GLP, V&V, CAPA, GMP
Education
Santa Clara University School of Law 2000 — 2004
JD, Law
Georgetown University 1996 — 1997
MS, Physiology
Holaira, Inc. March 2015 - Present
Holaira, Inc December 2012 - Present
Sole Proprietor June 2008 - January 2013
MAP Pharmaceuticals January 2006 - May 2008
BD Biosciences 1999 - 2006
Roche 1995 - 1996
Roche 1995 - 1996
Skills
Lifesciences, Clinical Trials, FDA, Biotechnology, Regulatory Affairs, Medical Devices, Licensing, ISO 13485, Pharmaceutical Industry, Technology Transfer, GLP, V&V, CAPA, GMP
Education
Santa Clara University School of Law 2000 — 2004
JD, Law
Georgetown University 1996 — 1997
MS, Physiology
Kyle True's Holaira, Inc. Experience August 2013 - Present
Job Senior Mechanical Engineer at Holaira
Industry Mechanical or Industrial Engineering
Experience
Holaira, Inc. August 2013 - Present
Boston Scientific February 2011 - August 2013
Boston Scientific September 2009 - January 2011
BAE Systems May 2009 - September 2009
University of Minnesota September 2008 - May 2009
University of Minnesota 2004 - 2009
BAE Systems May 2008 - August 2008
Boston Scientific May 2007 - September 2007
Boston Scientific May 2006 - August 2006
Skills
Medical Device R&D, Medical Devices, Product Development, Mechanical Engineering, Quality System, Electrical Stimulation, Catheters, Manufacturing..., Biomedical Engineering, Solidworks, Pro Engineer, Manufacturing, Production Development, Design of Experiments, Minitab, Design for Manufacturing, Engineering, Injection Molding, Connecting People, V&V, Testing, SolidWorks, PTC Creo
Education
University of Minnesota-Twin Cities 2007 — 2009
Masters, Mechanical Engineering
University of Minnesota-Twin Cities 2004 — 2007
Bachelors, Mechanical Engineering
Holaira, Inc. August 2013 - Present
Boston Scientific February 2011 - August 2013
Boston Scientific September 2009 - January 2011
BAE Systems May 2009 - September 2009
University of Minnesota September 2008 - May 2009
University of Minnesota 2004 - 2009
BAE Systems May 2008 - August 2008
Boston Scientific May 2007 - September 2007
Boston Scientific May 2006 - August 2006
Skills
Medical Device R&D, Medical Devices, Product Development, Mechanical Engineering, Quality System, Electrical Stimulation, Catheters, Manufacturing..., Biomedical Engineering, Solidworks, Pro Engineer, Manufacturing, Production Development, Design of Experiments, Minitab, Design for Manufacturing, Engineering, Injection Molding, Connecting People, V&V, Testing, SolidWorks, PTC Creo
Education
University of Minnesota-Twin Cities 2007 — 2009
Masters, Mechanical Engineering
University of Minnesota-Twin Cities 2004 — 2007
Bachelors, Mechanical Engineering