Human Factors Engineer
- Collaborate with cross-functional teams from various sites to define user needs and human factors requirements and plan and execute studies to meet product timeline.
- Design and develop formative and summative usability studies and oversee execution of the studies throughout the product life cycle. Create and review the human factors summaries for regulatory submissions.
- Author formative and summative usability study protocols and summary reports consistent with health authority expectations. Moderate studies, and analyze study data demonstrating knowledge and proficiency with basic statistics.
- Experience designing instructions for use (IFU) documents and training materials for medical devices and conducting usability testing of them.
- Advise Regulatory, Quality, and R&D teams regarding compliance with IEC 62366, FDA Human Factors Engineering Guidance, and HE75 guidance as well as design controls and risk management regulations for medical devices.
- Manage and drive company SOP’s/policies/procedure for alignment with human factors engineering standards and guidance documents.
- Identify tasks and workflow in collaboration with stakeholders to effectively manage the design of software and system interfaces for complex medical devices.
- Clearly communicate how study results can be implemented into design.
Bachelor's Degree in an Engineering or closely related discipline with two to four years of related work experience or sufficient transferable experience to demonstrate functional equivalence to a degree. Minimum 2 years’ experience.
- Bachelor's degree in human factors engineering, mechanical engineering, bioengineering, or related discipline
- 3+ years of experience in applying human factors engineering to medical devices
- Experience working cross-functionally on risk management activities
- Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
- High level of initiative and ability to work independently
LOCATION:United States > Santa Clara : 4551 Great America Parkway
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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