Role Description
We are seeking an experienced Human Factors Engineer to support the research, design, and validation of medical device products through user-centered design and usability engineering principles. The ideal candidate will have expertise in human factors research, usability testing, risk analysis, and regulatory compliance, partnering with cross-functional teams to ensure products are safe and effective for end users throughout the product development lifecycle.
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Conduct user research, interviews, task analyses, and simulated use studies to understand user needs and workflows.
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Plan, execute, and report formative and summative usability (Human Factors) studies.
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Perform usability risk analysis and maintain traceability between user risks, mitigations, and validation activities.
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Provide Human Factors guidance throughout product design and development.
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Analyze customer feedback and product complaints to identify usability improvements.
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Collaborate with Engineering, Product Management, Clinical, and Regulatory teams.
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Present research findings and usability recommendations to cross-functional stakeholders.
Qualifications
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5+ years of Human Factors Engineering or Usability Engineering experience.
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Strong experience conducting user research, task analysis, and usability testing.
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Experience with Human-Centered Design (HCD) and User-Centered Design (UCD) methodologies.
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Experience performing usability risk analysis and validation testing.
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Strong analytical, presentation, documentation, and communication skills.
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Ability to collaborate with cross-functional engineering and product development teams.
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Knowledge of Human Factors regulations and standards including IEC 62366, AAMI HE75, and FDA Human Factors Guidance.
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Bachelor's or Master's degree in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Psychology, Human-Centered Design, Computer Science, or a related field.
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Ability to travel domestically up to 25%.
Requirements
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Experience in the medical device or other regulated industries.
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Experience supporting FDA-regulated product development and usability validation.
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Familiarity with risk management and regulatory documentation.
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Strong understanding of product development lifecycles and usability engineering best practices.
Benefits
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W2 Only
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Duration: 12+ Months
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Location: Remote
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Pay Range: $110 - $120 per hour on W2