Senior Human Factors / Usability Engineer

About the role

The ideal candidate is a seasoned Human Factors Engineer who can quickly integrate into an existing team, independently drive usability engineering activities, and provide expert guidance on FDA-compliant human factors practices. They bring strong experience supporting medical device programs, demonstrate deep knowledge of use-related risk analysis, and have successfully contributed to 510(k) submissions and usability validation efforts.

We are seeking a Senior Human Factors Engineer to support the development and validation of medical devices through user-centered design, usability engineering, and regulatory compliance activities. This individual will serve as an experienced contributor capable of working independently with minimal supervision and partnering with cross-functional teams to ensure products meet user needs, regulatory requirements, and risk management standards. The contract duration is 1 year+ with possible extensions.

Responsibilities

• Lead and execute human factors and usability engineering activities throughout the product development lifecycle.
• Support the design and evaluation of electromechanical medical devices and associated Graphical User Interfaces (GUIs).
• Conduct and document formative and summative usability studies in accordance with FDA and industry standards.
• Identify, analyze, and mitigate use-related risks through comprehensive use error analysis and risk management processes.
• Contribute to regulatory submissions, including 510(k) documentation and human factors engineering deliverables.
• Collaborate with engineering, quality, regulatory, clinical, and product development teams to ensure usability requirements are incorporated into product design.
• Develop study protocols, moderation guides, reports, and supporting documentation for regulatory and internal stakeholders.
• Interpret FDA human factors guidance and ensure compliance with current regulatory expectations.
• Present findings, recommendations, and risk assessments to project teams and leadership.

Requirements

• Bachelor's degree in Human Factors Engineering, Industrial Engineering, Cognitive Psychology, Biomedical Engineering, or a related field.
• 5+ years of Human Factors Engineering, Usability Engineering, or related experience within a regulated industry.
• Experience supporting medical device development and FDA-regulated products.
• Demonstrated experience with 510(k) submissions and human factors documentation.
• Strong background in use error identification and analysis.
• Strong background in risk management.
• Strong background in formative usability studies.
• Strong background in summative validation studies.
• Strong background in human factors validation reporting.
• Experience with electromechanical devices and user interface evaluation.
• Ability to work independently and lead human factors activities with limited oversight.
• Strong written and verbal communication skills.

Qualifications

• Experience moderating usability studies.
• Knowledge of FDA Human Factors Guidance and relevant international standards.
• Experience supporting multiple product development programs simultaneously.
• Familiarity with healthcare, pharmaceutical, or combination product environments.

Pay

$70/hr

Schedule

Hybrid (3 days per week, flexible)