Owns pre-defined tasks within a larger usability engineering effort such as usability specifications, use error risk analysis, formative usability studies, and usability validation studies, and drives them to on-time, high quality completion.
Plans and conducts customer and competitive research to identify, prioritize/develop new projects, create detailed usability improvement plans/concepts, select/manage external usability design resources, and lead internal and external development resources.
Supporting usability deliverables for systems
Applies advanced usability improvement principles to the evaluation and solution of complex product design problems.
Remains abreast of and consults on usability improvement advancements.
Exercises independent judgment in the planning, organizing and performing work
Monitors performance and reports status to manager.
Investigates and defines usability requirements for new product/feature development and facilitates the translation into new projects through formative testing.
Works with field and medical personnel to define the user experience these products/features.
Gathers and analyzes use errors and issues for medical devices and translates these into specific system risk mitigations.
Creates detailed usability improvement concepts and leads design teams.
Works across product lines, internal departments, and company sites to create and manage usability improvement plans and usability standards.
Simulates or tests aspects of new projects to evaluate prototypes and optimizes the user experience.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Creates and refines usability related processes, and trains others in their use.
Produce documentation, reports and analysis that adheres to FDA Guidelines for usability, and IEC Standards 62366 and 60601-1-6.
BS/BA Degree in human factors engineering, human computer interaction, human factors psychology, biomedical engineering, or systems engineering
Minimum of 5 years of relevant work experience in medical product development and/or a graduate degree with relevant project experience.
Ability to apply understanding of human factors or usability engineering to issues in order to bring tasks to resolution within assigned projects.
Ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs.
Strong analytical, problem solving skills
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication ability
Can meet deadlines in timely manner.
Strong organizational and follow-up skills
Keen attention to detail.
Master’s or Doctoral Degree in human factors engineering, human computer interaction, human factors psychology, biomedical engineering, or systems engineering