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About the role
- 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)
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
- Paid time off
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