The Human Factors Engineer will provide human factors engineering expertise to project teams developing drug delivery devices at COMPANY, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered. The Human Factors Engineer will collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative products and ensure that those products are safe and easy to use. As part of product development, they will conduct human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies. They will also develop instructions for use and training materials for clinical trial and commercial purposes. 3 years of experience in applying HFE to medical device or combination product development Experience writing formative and summative usability study protocols and reports and human factors summary reports consistent with health authority expections Experience working cross-functionally on risk management activities Experience designing instructions for use (IFU) documents and training materials for medical devices\/combination products and conducting usability testing of them Experience working with human factors external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics Proven ability to clearly communicate how study results can be implemented into design Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combinations products Ability to communicate effectively in writing, verbally, and as a presenter Demonstrated time management, decision making, presentation, and organization skills Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team High level of initiative and ability to work independently Bachelors degree in human factors engineering, mechanical engineering, bioengineering, or related discipline
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