Brian Biersach

Brian Biersach Work

President, Senior Biomedical Engineer

@ MECA (Medical Equipment Compliance Associates, LLC)

D

Project Engineer (Medical Team)

@ Daikin Air Condition

Tutor

@ Milwaukee School of Engineering

Brian Biersach Education

1993 - 1997 Bachelor of Science - BS in Biomedical Engineering

Milwaukee School of Engineering
1985 - 1992 Bachelor of Arts - BA in Economics

University of Wisconsin-Milwaukee

Brian Biersach Skills

Medical DevicesFDACE markingIEC 60601TestingR&DProduct DevelopmentQuality SystemElectronicsValidationBiomedical EngineeringProduct SafetyRegulatory AffairsStandards ComplianceISO 14971ISO 13485IECULISOEngineeringV&VManufacturingHardware DiagnosticsProduct LaunchSoftware DocumentationMedical StandardsMedical Imaging21 CFRDesign ControlQuality ManagementCross-functional Team LeadershipDesign of ExperimentsCAPAQuality AssuranceCalibrationSix SigmaResearch and Development (R&D)ISO StandardsU.S. Food and Drug Administration (FDA)Verification and Validation (V&V)Corrective and Preventive Action (CAPA)Continuous ImprovementMicrosoft OfficeCorrective and Preventive Action CapaComplianceCross Functional Team LeadershipHealthcareBiomedical EngineerMedical Equipmentu.s. Food and Drug Administration FdaVerification and Validation V&VResearch and Development R&du.s. Food and Drug AdministrationResearch and DevelopmentVerification and ValidationCorrective and Preventive Action

Brian Biersach Contact Information

Work email●●●●●●●●@company.com

Personal email●●●●●●●●@gmail.com

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Brian Biersach currently works at MECA (Medical Equipment Compliance Associates, LLC).

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Where is Brian Biersach located?

Brian Biersach is based in or around Franklin, WI, US.

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