Chelmsford, United States
over 4 years ago
Senior Usability Engineer
As a Senior Usability Engineer, there will be opportunities to establish and refine usability and human factors requirements for new and enhanced products as part of a cross functional team. You may be a Usability Task Leader on multiple projects, contributing to best-practice development within the Usability team as well as executing on those best practices. Key to your role will be your ability to communicate with representative users and to work well with internal stakeholders. Approximately 20% travel.
- Create documents for design history files and tech files, including use specifications, usability plans, task analyses, use error analyses, usability assessments, usability audits, and usability engineering files. Review other Usability team members’ documentation.
- Work closely with cross-functional development teams to ensure that user needs and usability requirements are identified and addressed throughout the development lifecycle.
- Provide on-going usability support on assigned projects. Participate in design reviews and make usability recommendations.
- Drive early identification of use-related hazards and participate in use risk analysis
- Develop test protocols, recruit participants, conduct usability testing, compile and analyze test results, and write usability test reports
- Conduct MAUDE searches and perform complaint analysis
- Keep pace with medical device national and international guidances that have a usability engineering impact and understand how to apply those guidances
- Working knowledge of IEC 62366, 60601-1-6, MDR, and HE75. BS or MS in Human Factors Engineering, Biomedical Engineering, or other engineering (software, mechanical, etc.) with medical concentration.
- 5+ years of usability experience (at least 2 years in the medical device industry).
- Practical experience applying IEC 62366, 60601-1-6, MDR, and HE75 to medical device design and development.