1 senior manager international risk assessments jobs found in Irvine

Creative Circle Medical device client is seeking a R&D Device Engineer for Medical Devices with a degree in Human Factors to join their team. This is a 40 hour/week, ongoing contract opportunity with the potential for full-time conversion. This role does require 4 days/week onsite in Irvine, CA. The ideal candidate Must Have: -University/Bachelor's Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology or Equivalent. -3+ years work experience in human factors/usability engineering. -Hands-on involvement in FDA submissions (PMA, 510(k)) and EU MDR compliance. -Demonstrated ability to lead project-level human factors activities, including contextual inquiry, ethnographic studies, requirements definition, use-related risk analysis, formative usability assessments, and summative evaluation studies. -Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk...