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Biography
Mr. Lubas has over 5 years of experience leading or working on a variety of medical devices from emergency-use combination products to surgical devices intended for low-resource and military environments. As a Human Factors Engineer with a mechanical and biomedical engineering background, Mr. Lubas focuses on creating user-centric products that promote safe and effective use of the device. Mr. Lubas has a versatile skillset encompassing a wide spectrum of product development, computed aided design (CAD), risk analysis, human factors and user experience research capabilities. Mr. Lubas also has a background in global regulatory submissions and has led companies through ISO 13485 QMS audits as a quality specialist. Mr. Lubas has participated in all stages of the human factors assessment process, from early client collaboration in study planning, contextual and conceptual research, protocol development, coordinating of recruiting, IRB submission and approval, risk analysis, study planning and execution, and report writing and results presentation.