Chelmsford, MA 01824
- 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
- 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
- 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.
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.
Don' t feel you are the best fit for this job but know someone who is? Refer someone who is hired for this role (or ANY other) and we will offer you a referral bonus for helping us to keep our client happy.
Please be sure to sign up for email notifications when we post a new opening, or check back with http://jobs.techneeds.com to see our list of other openings.