Joe Melnick

Ai Systems Engineering Manager - Center for Digital Health @Mayo Clinic

San Jose, CA, US
MOBILE NUMBERS
+12•••••••15

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WORK HISTORY

Jan 2022 — Present

Ai Systems Engineering Manager - Center for Digital Health @Mayo Clinic

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US

EDUCATION

2000 — 2005

Worcester Polytechnic Institute

Bachelors of Science, Industrial Engineering

SKILLS

CathetersLean ManufacturingQuality SystemV&VSpc21 Cfr Part 11Management ReviewCe MarkingSix SigmaQuality AuditingFmeaU.s. Food and Drug Administration (Fda)Design of ExperimentsManufacturingValidationCqeDmaicManufacturing EngineeringDesign ControlIsoFdaFda GmpMedical DevicesCapaIso 13485Quality AssuranceDesign for ManufacturingContinuous Improvement21 CfrChange ControlSupplier QualityIso 14971Root Cause AnalysisCqaMinitabQuality ControlGmpSupplier Quality Management

ABOUT JOE MELNICK

Joe Melnick is a seasoned engineering professional with 20 years of experience in the medical device industry, currently serving as the AI Systems Engineering Manager at the renowned Mayo Clinic Center for Digital Health. His expertise lies in navigating the intricate landscape of design controls, with a particular interst in Software as a Medical Device (SaMD). Joe\'s proficiency extends to the development and implementation of FDA guidance documents related to medical device development, software, SaMD, clinical decision support software, and risk management. Throughout his career, he has been instrumental in translating medical devices into clinical practice, ensuring that technological advancements align with patient care standards. His comprehensive understanding of the regulatory environment, combined with his hands-on experience in product development, positions Joe as a leading figure in the integration of innovative medical technologies into healthcare.

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