Perform human usability engineering activities in partnership with functional engineering groups (Software, Firmware, Electrical, Mechanical and Systems), new product planning, clinical, design assurance, regulatory, and marketing. Develop research methodologies to collect both qualitative and quantitative data, as needed. Design and execute both formative and summative usability tests to simulate product use. Support and author deliverables related to user needs, development of user profiles, use scenarios, task and use error analysis, usability testing, and post-market usability analysis for continuous improvement. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, and across multiple disciplines
Education/Experience:
4+ Years of relevant work experience in medical device product development and/or a graduate degree with a relevant project experience.
Degree types:
Pre-med, Human Factors, Psychology, Bio-med, related. Prior experience working with medical device hardware (ideally class III, implantable) Strong analytical and problem-solving skills in a team environment Experience moderating usability sessions and documenting findings Ability to work within a team and as an individual contributor in a fast-paced, dynamic environment Knowledge of IEC 62366, 60601-1-6 and FDA guidelines for Human Factors. #