Primary Skills: Human Factors Engineering (Expert), Usability Testing & Validation (Expert), User Research & Task Analysis (Expert), Human-Centered Design / HCD (Advanced), Medical Device Usability (Advanced)
Contract Type: W2 Only
Duration: 12+ Months
Location: United States, Remote
Pay Range: $110 - $120 per hour on W2
Job Summary: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, effective for end users throughout the product development lifecycle.
Key Responsibilities:- Conduct user research, interviews, task analyses, and simulated use studies to understand user needs and workflows.
- Plan, execute, and report formative and summative usability (Human Factors) studies.
- Perform usability risk analysis and maintain traceability between user risks, mitigations, and validation activities.
- Provide Human Factors guidance throughout product design and development.
- Analyze customer feedback and product complaints to identify usability improvements.
- Collaborate with Engineering, Product Management, Clinical, and Regulatory teams.
- Present research findings and usability recommendations to cross-functional stakeholders.
Must-have Skills:- 5+ years of Human Factors Engineering or Usability Engineering experience.
- Strong experience conducting user research, task analysis, and usability testing.
- Experience with Human-Centered Design (HCD) and User-Centered Design (UCD) methodologies.
- Experience performing usability risk analysis and validation testing.
- Strong analytical, presentation, documentation, and communication skills.
- Ability to collaborate with cross-functional engineering and product development teams.
- Knowledge of Human Factors regulations and standards including IEC 62366, AAMI HE75, and FDA Human Factors Guidance.
- 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.
- Ability to travel domestically up to 25%.
Nice-to-have Skills:- Experience in the medical device or other regulated industries.
- Experience supporting FDA-regulated product development and usability validation.
- Familiarity with risk management and regulatory documentation.
- Strong understanding of product development lifecycles and usability engineering best practices.
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