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Usability Engineer/Human Factors Engineer

Chelmsford, MA
Usability Engineer/Human Factors EngineerOur Client is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. Our client’s products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest.
As a Usability Engineer II, you will work with cross-functional teams to provide usability support for new products and product enhancements throughout the development life cycle. This includes developing usability plans and protocols, conducting use-related hazards analysis, planning and executing formative and summative usability test and providing usability support for regulatory submissions and design history files. Key to your success will be your ability to communicate well with users, and to collaborate with development teams. Occasional travel.
Essential Functions:
  • Create usability documentation for design history files and tech files, including usability plans, use specifications, task analysis, use error analysis, usability assessments for feature modifications, usability audits, usability engineering files, and HFE/UE reports
  • Drive the early identification of use-related hazards and participate in use risk analysis
  • Work closely with cross-functional development teams to ensure that user needs and potential use-related hazards are identified and addressed throughout the development lifecycle.
  • Develop test protocols, recruit participants, conduct usability testing, analyze test results and write formative and summative usability test reports
  • Conduct MAUDE searches and perform complaints analysis as needed
  • Keep pace with medical device national and international standards and guidance's that have a usability engineering impact and understand how to apply them
  • Contribute to refining internal usability best-practices
Skills Requirements:
  • Working knowledge of the FDA UE Process Guidance, IEC 62366, 60601-1-6, MDR, andHE75
  • Strong communication and writing skills. Must be comfortable interacting with customers/users, can communicate ideas effectively to internal stakeholders
  • Works with minimal supervision. Reports project, schedule and objective status
  • Collaborator and team player; works well with the Usability team and project teams
  • Experience with medical device simulation tools a plus
Required/Preferred Education and Experience:
  • BS or MS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline preferred (software, mechanical, etc.)
  • 2 + years of medical device usability engineering experience
  • Practical experience applying IEC 62366, FDA Guidance, MDR, and HE75 in an end-to-end medical device development project

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