Human Factors Engineering

Company: IDC Technologies
Location: Lowell
Posted on: November 23, 2020

Job Description:

Human Factors Engineering Cambridge MA Contract Job Description The Human Factors Engineer will provide human factors engineering expertise to project teams developing combination product drug delivery devices. Writing medical device validation protocols, executing test and coordinating with third party to perform test Writing formative and summative usability study protocols and reports and human factors summary reports consistent with regulations To consider all aspects of the user, the intended use, the use environment, and the drug therapy being delivered in applying human factors engineering during the product development. 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, the engineer will lead the team to 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. He will also develop instructions for use and training materials for clinical trial and commercial purposes. SkillsQualifications Masterrsquos degree in human factors engineering, mechanical engineering, bioengineering, or related discipline with PhD in related field 5 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 regulations Experience working cross-functionally on risk management activities Experience designing instructions for use (IFU) documents and training materials for medical devicescombination 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 guidancersquos for medical devices and combinations products

Keywords: IDC Technologies, Lowell , Human Factors Engineering, Other , Lowell, Massachusetts