Human Factors Study Manager -( medical device or drug-device Experience)

Bio-Tech

****Expectation is candidate will be required onsite once COVID restrictions are lifted*****

The Human Factors Engineer (HFE) Study Manager is responsible for supporting activities related to human factors planning, stimuli implementation, study logistics, participant recruitment, study management, vendor liaison, data management and report generation. This person is expected to collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. The study manager will help to generate high quality studies and human factors data, providing critical support for product, labeling, packaging, instructional design, validation, clinical study, and regulatory submission activities.

Top 3 Must Have Skill Sets:

* Masters degree and 3 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience OR Bachelors degree and 5 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience
* Experience supporting or leading various human factors methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, one-on-one interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies
* Must have an ability to successfully work in device development environment that relies on design controls, cross-functional team decision making, and complex and challenging decision pathways.