Job Description

Key Responsibilities:

• Advocate for patient safety and ease of use in product design
• Support product teams in defining usability and ergonomic requirements
• Conduct and analyze usability testing, ethnographic research, and interviews
• Provide heuristic design guidance and feedback on user interfaces
• Develop risk analyses, user profiles, task analyses, and HF reports for regulatory compliance
• Draft uFMEAs and Use Error Analyses to identify potential use-related hazards
• Investigate usability-related complaints on existing products
• Collaborate on usability evaluations, regulatory submissions, and risk assessments
• Mentor junior engineers and teams on human factors best practices

Qualifications & Skills:

• BS in Engineering or related technical field (MS preferred)
• 6+ years in Human Factors/Usability Engineering (5+ with MS/PhD)
• Medical device design & development (Class II or III preferred)
• Strong knowledge of usability standards (ISO 14971, IEC 62366-1, FDA guidelines, etc.)
• Experience conducting usability evaluations and risk analyses
• Excellent communication, analytical, and multitasking skills
• Basic understanding of system, electrical, mechanical, and software design

Bonus Skills:

• Experience with complex electro-mechanical systems, fluidic/disposable components
• Working with third-party service providers and external certification labs

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