Professional Experience Quality Assurance

BEN BAILEY

*** ********* **** • Coppell, TX *****

972-***-**** • ***.******@*******.***

PROFILE

Expert Biomedical Engineer seeking an opportunity to pursue new challenges with a device manufacturer or service provider. Extensive background and expertise in Holter, stress and diagnostic ECG through a career spanning 20 successful years so far. Highly familiar with ECG signal processing, product design, regulatory affairs and all skills required to produce a quality medical product. QRS Detection Rhythm Analysis ECG Noise Detection

ECG Interpretation Real-Time ECG Holter Editing

FDA EN ISO 13485 CMDCAS

PROFESSIONAL EXPERIENCE

Pulse Biomedical King of Prussia, PA 1992 – Present VP SOFTWARE SYSTEMS

Product Design:

Principal architect for the software and firmware for following products:

• PC Cardiology Suite -(http://www.qrscard.com/download/CardioSuite/V406/qrscrdenu.msi)

• Android Cardiology Suite - (https://play.google.com/store/apps/details?id=qrs.stwin&hl=en)

• iOS Cardiology Suite - (https://itunes.apple.com/us/app/cardiology-suite/id798777528?mt=8)

• ASP.NET Cardiology Suite - (www.cardioremoteusa.com)

• QRS-Card BT - (www.qrscard.com)

Cardiology:

Principal scientist for the evaluation of ECG signals

• Holter ECG - Detection Algorithm (beat detection, beat classification, etc.), Editor Workstation, Final Report

• Stress ECG - Real-Time Detection Algorithm (beat detection, classification, etc.), Real-Time ECG Acquisition, Treadmill Ergometer control, Final Report

• Diagnostic ECG - Real-Time Detection Algorithm (beat detection, classification, etc.), Diagnostic Interpretation Algorithm, Real-Time ECG Acquisition, Final Report Engineering:

Fluent in multiple architectures and languages.

• Architectures - PC, ASP.NET, iOS, Android, TI MSP430. STM32, linux

• Languages - C, C++, C#, objective C, assembly, JAVA, etc. Quality Assurance

Worked with QA to accredit multiple products

• FDA - Participated in multiple 510 K Applications and site audits.

• EN ISO 13485 / CMDCAS - Principal architect for the company quality system. Participated in multiple surveillance audits

PRODUCT DISTRIBUTION

Worked with companies, including those below, that incorporate the above products into their product or workflow: Jaeger / CareFusion Rozinn / ScottCare ECardio / Preventice Oxford Instruments Ergoline INeedMD

EDUCATION

Drexel University 1987

Ph.D. in Biomedical Engineering

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