Human Factors Engineer enhancing product usability and safety through assessments in medical devices. Collaborating with teams to develop patient-centric designs and improve cardiac health solutions.
Responsibilities
Support execution and documentation for usability engineering evaluations
Support authoring of formative and summative usability study protocols
Support coordinate and moderate formative usability studies
Support root cause analysis and aggregate data for presentations and formal reports
Partner with external vendors as required to execute human factors evaluations
Update usability risk analyses in collaboration with cross-functional stakeholders
Collaborate with Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation
Work with design teams to create patient-centric and compliant designs
Requirements
BS in Human Factors or in a science/engineering discipline with relevant experience and 1+ years of Human Factors experience in design-controlled processes, specifically in regulated domains like medical devices
Must understand regulatory requirements and possess knowledge of medical device design and FDA guidelines
Familiarity with HE75 and IEC 62366-1, -2
Demonstration of technical problem-solving, interpersonal, and communication skills (verbal and written)
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