Senior Human Factors Engineer (Onsite Services)
- Bachelor’s or Master’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field is preferred
- Minimum 4 years of applied experience in Human Factors or Usability Engineering; Medical Device experience is strongly preferred.
- Demonstrated experience in the planning and conduct of various user research activities, including ethnography, formative and summative usability studies, and documentation for design control and risk management
- Strong knowledge of human factors principles; working knowledge of task and use-related risk analysis methods; basic knowledge of human perception, cognition, anthropometrics, biomechanics, and physiology
- Experience consolidating user feedback into concise, meaningful design insights and actionable recommendations. Experience performing root cause analysis for use-related problems is preferred
- Familiarity with FDA, ISO, IEC, AAMI, and other relevant usability standards and guidances for medical devices is highly preferred
- Support front-end ethnographic activities, including observational research and in-context interviews, and consolidate observations into meaningful use-related date
- Plan and coordinate usability studies at various stages of product development from early prototypes through formal human factors validation/summative usability testing. Activities may include writing and executing test protocols, moderating studies, analyzing test data, performing thoughtful and thorough root cause analysis, and writing test reports
- Collaborate with project team on task analyses and use-related risk analyses (AMFEA/UFMEA)
- Make user interface design recommendations based on known use problems with predicate devices, user feedback, empirical data, literature searches, and industry best practices.
- Ensure compliance to internal usability procedure and latest Human Factors standards and guidances
- Prepare and review documentation for submission to regulatory agencies and notified bodies. Answer questions and provide rationales as needed.
- Represent the Human Factors function on multiple projects concurrently, working with cross-functional teams including Industrial Design, R&D, Clinical, Marketing, Quality, and Regulatory.
- Strong written and verbal communication skills
- Up to 20% travel required