Clinical R&D Engineer

Position –  Clinical R&D EngineerLocation – Remote – Occasional travel to Los Angeles, CADuration-  12+ MONTHS Interview: Video Job Description:  Seeking a Clinical R&D Engineer with strong medical device development experience and the ability to translate clinical requirements into product development, validation, and regulatory activities.Must HaveBachelor's degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science6+ years of relevant medical product development experienceClinical requirements and clinical evaluation experienceExperience with preclinical evaluation protocols, data analysis, and reportsExperience supporting validation, feasibility, usability, and human factors studiesExperience contributing to Clinical Evaluation Reports (CERs)Knowledge of FDA regulations and medical device developmentStrong collaboration across Clinical Affairs, Engineering, Regulatory, and MarketingPreferred DomainCardiovascular / Structural HeartTAVR, TMVR, TTVRCardiac imaging and CT workflowsClinical trials and submission studiesMedical device software/product developmentKey ResponsibilitiesDefine clinical requirements and product benchmarksDevelop and direct clinical/preclinical evaluation protocolsAnalyze clinical and research dataSupport product validation and usability studiesContribute to risk management files and CERsCollaborate with clinical, engineering, and regulatory teams throughout the product lifecycleGTECH LLCKapil Dev Teotia| Senior Technical RecruiterMobile (469)270-8064|Email kteotia@greattechglobal.com