Job Post Index 22C426-Sy##
Location Virtual, US
Description: Description
  • 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.
Skills: Qualification
  • 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.
Preferred Qualification
  • Master’s or Doctoral Degree in human factors engineering, human computer interaction, human factors psychology, biomedical engineering, or systems engineering
  • Medical device experience
  • Familiar with EU-MDR
  • Familiar with IEC Standards 62366 and 60601-1-6.
  • DOORS experience

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