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Human Factors Engineer

2 months ago


Cambridge, Massachusetts, United States HRM INFO LLC Full time
Job Summary

Clients, a leading developer of innovative medical products, is seeking an experienced Human Factors Engineer to join our cross-functional product development team. As a key member of our team, you will collaborate with clinicians and hospital staff across the country to define and validate user requirements for cutting-edge medical devices.

Key Responsibilities
  • Lead usability testing to understand users, use environments, and user characteristics.
  • Collect and analyze user behavior through lab studies, field visits, ethnography, and surveys.
  • Develop designs and hardware/software requirements for innovative user interfaces.
  • Support the documentation and organization of activities needed to achieve 510k approval.
  • Work with multi-disciplinary teams made up of engineering, marketing, quality, legal, and manufacturing.
  • Incorporate best practices from human factors and user interface design.
  • Develops and maintains an understanding of the latest information regarding usability/human factors testing for medical devices.
  • Work with outside vendors and consultants.
Results Expected
  • Identify, define, and document user interface for a medical device product.
  • Create, document, and execute usability test protocols.
  • Document test reports in accordance with the Canon documentation standard operating procedures.
  • Disclose documented inventions to the patent team.
Qualifications
  • Bachelor's degree in Human Factors Engineering or other appropriate field with a human factors concentration.
  • 3 years of demonstrated experience developing GUI and conducting user research.
  • Knowledge of ANSI HE75, ISO 14971, IEC 60601, IEC62366.
  • Experience moderating user studies.
  • Excellent English written and oral communication skills.
Nice to Haves
  • M.S. or PhD in Human Factors Engineering, or other appropriate field with a human factors concentration.
  • 5+ years of demonstrated experience developing GUI and conducting user research, preferably in the medical arena.
  • Experience in software architecting and software implementation.
  • Experience with Balsamiq and Adobe XD.
  • Experience working with FDA guidelines.
Required Skills
  • User Requirements
  • Usability
  • Offers
  • Interfaces
  • Product Development
  • Travel
  • Manufacturing
  • Vendors
  • Research
  • Documentation
  • Software
  • Testing
  • Design
  • Engineering
  • Marketing
  • Business
  • English
  • Communication