• Kaleidoscope Animations
  • $111,680.00 -166,760.00/year*
  • Bergenfield , NJ
  • Engineering
  • Full-Time
  • 30 W Clinton Ave


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Kaleidoscope Careers
Senior Human Factors Engineer
Onsite Services Sommerville, New Jersey
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Qualifications
* 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
Key Responsibilities
* 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
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* 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


Associated topics: biochemistry, biological engineer, biology, biomedical, bioprocess, bioprocessing, neurodegenerative, nutrition, pathogenesis, pharmaceutical

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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