Human Factors Engineer

Human Factors Engineer

Overview

We are seeking an enthusiastic, collaborative Human Factors Engineer to support the design and development of safe, effective, and user-friendly medical devices within the diabetes-care space. This role will contribute to Human Factors activities across the full product lifecycle, working closely with cross-functional teams to ensure world-class usability and patient safety.

Key Responsibilities

• Author, review, and maintain Human Factors documentation, including usability plans, use specifications, UI specifications, risk analyses, and formative and validation protocols/reports.
• Plan, conduct, and report Human Factors formative and validation studies.
• Analyze qualitative data, perform root cause analyses, and provide actionable design recommendations.
• Collaborate cross-functionally to identify, assess, and mitigate use-related risks.
• Provide research and design inputs related to human capabilities and user interaction.
• Support continuous improvement of Human Factors processes and documentation.

Qualifications

• Bachelor’s degree in Human Factors, HCI, Cognitive Science, Biomedical Engineering, or related field (Master’s preferred).
• 1–3 years of Human Factors experience; medical device experience preferred.
• Strong written and verbal communication skills.
• Highly collaborative, analytical, and self-motivated.
• Ability to manage multiple tasks and contribute in fast-paced environments.
• Willingness to travel within the U.S. up to 25% for usability studies.

Preferred Skills

• Knowledge of FDA Human Factors Guidance and standards such as IEC 62366 and HE75.
• Experience with user-centered design methods.
• Hands-on experience conducting and moderating usability studies.
• Understanding of human performance principles (cognitive, perceptual, motor, and biomechanical).
• Ability to apply Human Factors principles to medical device design and evaluation.