What are the responsibilities and job description for the Human Factors Engineer position at Advantage Technical?
Human Factors Engineer
Overview
A growing medical technology organization is seeking an enthusiastic, team‑focused Human Factors Engineer to support the design and evaluation of safe, effective, and user‑friendly medical devices. This role is part of a small, collaborative Human Factors team working on next‑generation products in the diabetes‑care space.
The ideal candidate brings experience in Human Factors engineering, thrives in cross‑functional environments, is naturally curious, and is motivated by improving patient safety and usability.
Responsibilities
Human Factors Documentation
Author, review, and edit Human Factors engineering documentation, including:
- Formative study protocols and reports
- Validation study protocols and reports
- Usability Plans
- Use Specifications
- User Interface Specifications
- Use‑Related Risk Analyses
Study Planning & Execution
- Plan, execute, and report on Human Factors formative and validation studies to support medical device design optimization.
- Conduct qualitative data analysis and root‑cause investigations based on study findings.
- Provide actionable design recommendations and prepare presentations summarizing study outcomes.
Cross‑Functional Collaboration
- Work closely with product development teams to ensure use‑related risks are fully evaluated and appropriate risk controls are implemented.
- Provide research and design inputs related to human capabilities, user needs, and product interactions.
- Contribute to verification and validation activities for medical devices.
Continuous Improvement
- Support initiatives to strengthen Human Factors processes, documentation quality, and team best practices.
Education & Experience
Minimum Requirements
- Bachelor’s degree in Human Factors, Human‑Computer Interaction, Cognitive Science, Biomedical Engineering, or related field.
- Master’s degree preferred.
- 1–3 years of relevant experience; Human Factors experience in the medical device industry preferred.
- Strong verbal and written technical communication skills.
- Ability to self‑manage, prioritize, and collaborate effectively in multidisciplinary teams.
- Ability to plan and conduct effective meetings and presentations.
- Willingness to travel within the United States to support formative and validation studies (up to 25%).
Preferred Skills & Competencies
- Working knowledge of FDA Human Factors Guidance and relevant standards (HE75, IEC 62366).
- Experience with user‑centered design methods.
- Experience conducting and moderating Human Factors formative and validation studies.
- Understanding of human performance principles (perceptual, cognitive, motor, biomechanical, anthropometric).
- Ability to apply Human Factors principles to the design, evaluation, and use of medical devices.