Avinash Konkani

Human Factors Evaluator @FDA

Silver Spring, MD, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2023 — Present

Human Factors Evaluator @FDA

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Silver Spring, MD, US

In my role at the FDA, I contribute to the prevention and surveillance of medication errors by leveraging human factors expertise. Working alongside clinicians, health scientists and pharmacists, I support the scientific review processes for biological and drug products, ensuring safety and effectiveness in medication delivery.

EDUCATION

2010 — 2014

Oakland University

Ph.D., Systems Engineering

2003 — 2005

Wright State University

M.S., Biomedical and Human Factors Engineering

1997 — 2001

Karnatak University

B.E., Biomedical Engineering

SKILLS

Biomedical EngineeringMedical DevicesResearchHealthcareClinical ResearchData AnalysisBiomechanicsPatient SafetyLeadershipTeachingStatisticsSystems EngineeringHospitalsMicrosoft OfficeProject ManagementErgonomicsQualitative ResearchAnalysisTestingHuman FactorsTechnical WritingProject PlanningDesign of ExperimentsExperimental DesignHuman Factors EngineeringDecision AnalysisResearch DesignTeamworkTask AnalysisDiscrete Event SimulationSoftware InstallationBiomedical InstrumentationIrbProject ImplementationProject ExecutionMedical Equipment PlanningHealthcare Information Technology (Hit)

ABOUT AVINASH KONKANI

As a Human Factors Evaluator at the U.S. Food and Drug Administration\'s (FDA\'s) Center for Drug Evaluation and Research (CDER) I contribute to the vision and the mission of Division of Medication Error Prevention and Analysis (DMEPA) by collaborating with a multidisciplinary team of clinicians, pharmacists, health scientists, and patient safety experts. My work centers on applying biomedical engineering, human factors, systems engineering, and clinical engineering principles to proactively identify and mitigate medication errors associated with drug, biological, and combination products.With prior roles as a Biomedical Engineer at the FDA\'s Center for Devices and Radiological Health (CDRH) and as a Senior Clinical Engineer at Beth Israel Deaconess Medical Center and the University of Virginia Health System, I bring more than 16 years of experience in healthcare technology management, medical device usability, human factors in healthcare and patient safety and post-market surveillance of medical devices.My career has been driven by a deep commitment to patient safety and a passion for systems thinking that support safer, more intuitive healthcare delivery.I thrive in cross-functional settings where engineering meets clinical insight, and I’m energized by opportunities to solve complex challenges that improve outcomes for patients, caregivers and healthcare professionals. Whether evaluating medical device user interfaces or contributing to regulatory strategies, I aim to advance patient safety and healthcare through critical thinking, systems engineering approach and evidence-based evaluation.

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