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Usability Engineer

Chelmsford, MA 01824

Employment Type: Contract Industry: Engineering Job Number: 51604
As a usability engineer, you will work with cross-functional teams to provide usability support for new products and product enhancements throughout the product development life cycle. This includes developing usability plans and protocols, use related hazards analysis, planning and executing formative and summative usability testing and providing usability documentation for regulatory submissions and design history files. Key to success will be your ability to communicate well with representative users, and to collaborate well with development teams. Approximately 20% travel is required. 

Essential Functions: 
  • Create usability documentation for design history files and tech files, including usability plans, use specifications, task analysis, 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 guidelines that have a usability engineering impact and understand how to apply them 
  • Contribute to refining internal usability best-practices
Skill Requirements: 
  • Familiarity with the product development process and the guidelines for medical device usability including the FDA UE Process Guidance, IEC 62366, 60601-1-6, MDR, and HE75 
  • Strong communication and writing skills. Must be comfortable interacting with customers/users, and be able to communicate ideas effectively to internal stakeholders. 
  • 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.)
  • 0-2 years experience in Usability. Preferably with an internship or summer job exposure to clinical perspective of medical devices. 
Other Duties: 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities, that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification. 
 
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