Description:
JOB TITLE: Senior Human Factors Engineer
Day to Day Responsibilities:
"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
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
MUST HAVE THE FOLLOWING REQUIREMENTS:
"4+ Years of relevant work experience in medical device product development and/or a graduate degree with a relevant project experience. Prior experience working with medical device hardware (ideally class III, implantables)
Degree types: Pre-med, Human Factors, Psychology, Bio-med, related.
"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
"Excellent verbal and written communication skills and the ability to positively influence individuals and groups
"Strong organizational skills as well as attention to detail
"Knowledge of IEC 62366, 60601-1-6 and FDA guidelines for Human Factors. This must be clearly indicated on resume.