Project Engineer (Medical Team) @ (June 1997 - November 2002)
Tutor @ (January 1996 - May 1997)
Electronics and Materials @ (April 1993 - September 1996)
(Company was ACA - Alerting Communicators of America): Electronics design, assembly, fabrication @ (August 1982 - March 1993)
Brian Biersach Education
Milwaukee School of Engineering
Bachelor of Science - BS (Biomedical Engineering)
1993-1997
University of Wisconsin-Milwaukee
Bachelor of Arts - BA (Economics)
1985-1992
Brian Biersach Skills
Medical Devices
FDA
CE marking
IEC 60601
Testing
R&D
Product Development
Quality System
Electronics
Validation
Biomedical Engineering
Product Safety
Regulatory Affairs
Standards Compliance
ISO 14971
ISO 13485
IEC
UL
ISO
Engineering
V&V
Manufacturing
Hardware Diagnostics
Product Launch
Software Documentation
Medical Standards
Medical Imaging
21 CFR
Design Control
Quality Management
Cross-functional Team Leadership
Design of Experiments
CAPA
Quality Assurance
Calibration
Six Sigma
Research and Development (R&D)
ISO Standards
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Corrective and Preventive Action (CAPA)
Continuous Improvement
Microsoft Office
Corrective and Preventive Action Capa
Compliance
Cross Functional Team Leadership
Healthcare
Biomedical Engineer
Medical Equipment
u.s. Food and Drug Administration Fda
Verification and Validation V&V
Research and Development R&d
u.s. Food and Drug Administration
Research and Development
Verification and Validation
Corrective and Preventive Action
Brian Biersach Summary
Brian Biersach, based in Franklin, WI, US, is currently a President, Senior Biomedical Engineer at MECA (Medical Equipment Compliance Associates, LLC). Brian Biersach brings experience from previous roles at Underwriters Laboratories, Inc., Milwaukee School of Engineering, Milwaukee Electronics and American Signal Corporation. Brian Biersach holds a 1993 - 1997 Bachelor of Science - BS in Biomedical Engineering @ Milwaukee School of Engineering. With a robust skill set that includes Medical Devices, FDA, CE marking, IEC 60601, Testing and more. Brian Biersach has 2 emails and 1 mobile phone numbers on RocketReach.
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