Sr. Human Factors Engineer

Proclinical; San Diego (CA); Remote; USD 83,000 - 106,000; Full time

Job summary

Proclinical is seeking a Senior Human Factors Engineer for a remote contract role in the US. The role leads HF activities across the product lifecycle for safe, effective medical devices, collaborating with cross-functional teams and ensuring compliance with FDA IEC-62366 HE75 standards.

Ideal candidate holds a BS in HF/related field (MS/PhD preferred) with 5+ years in medical devices and up to 25% travel. Strong communication and mentorship are required.

Qualifications

• Bachelor's degree in Human Factors, HCI, Cognitive Science, Biomedical Engineering, or related discipline. Master's or Ph.D degree preferred.
• 5+ years of work experience including 3 or more years of relevant Human Factors engineering experience in the medical device industry
• Ability to self-motivate and self-manage.
• Excellent verbal and written technical communication skills.
• Ability to plan and conduct effective meetings and presentations.
• Ability to collaborate effectively in multi-disciplinary teams.
• Willingness to travel as needed (up to 25% of the time).

Responsibilities

• Author, review, and edit Human Factors engineering documentation related to assigned projects. This includes research protocols, research reports, Usability Engineering plans, Use-Related Risk Analyses, and other design control documentation.
• Support continuous improvement initiatives to strengthen Human Factors practices and documentation.
• Work cross functionally with the core team to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
• Ensure our client's Human Factors Engineering process follows compliance within FDA recognized guidance and standards including IEC-62366, HE75, and others.
• Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and the validation of medical devices.
• Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
• Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices.
• Participate in the development of product requirements and evaluation of risks related to product use (risk analysis)

Skills

Human Factors

Regulatory compliance

Usability testing

Risk analysis

User-centered design

Mentoring

Documentation

Education

Bachelor's in Human Factors / related field

Master's or PhD preferred

Job description

Sr. Human Factors Engineer - Contract - Remote - US

What if your Human Factors expertise could directly improve patient outcomes and influence the next generation of healthcare technology?

Proclinical is partnered with our client for an exciting opportunity for an experienced Senior Human Factors Engineer to join a collaborative team focused on the development of innovative healthcare technologies. The role involves applying human factors expertise across the product lifecycle to ensure products are safe, effective, user-friendly, and compliant within a regulated environment.

This position is remote within the United States.

Primary Responsibilities:

The successful candidate will apply Human Factors principles to the design, evaluation, and validation of innovative healthcare products and systems, providing technical leadership throughout the product development process. Working closely with cross-functional teams, they will contribute to usability engineering activities, support regulatory compliance requirements, identify user needs and risks, and help deliver safe, effective, and intuitive solutions that improve end-user outcomes.

Skills & Requirements:

Education and Experience

• Bachelor's Degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or related discipline. Master's or Ph.D degree preferred.
• 5+ years of work experience including 3 or more years of relevant Human Factors engineering experience in the medical device industry
• Ability to self-motivate and self-manage.
• Excellent verbal and written technical communication skills.
• Ability to plan and conduct effective meetings and presentations.
• Ability to collaborate effectively in multi-disciplinary teams.
• Willingness to travel as needed (up to 25% of the time).

Competencies:

• Deep expertise in effectively and efficiently documenting Human Factors Engineering deliverables in the medical devices industry
• Demonstrated experience with use-related risk analyses on medical devices
• Background knowledge in diabetes and diabetes-care devices strongly preferred
• Deep understanding of FDA's Human Factors Guidance and recognized standards (HE75, IEC-62366) related to medical devices, as well as theories, principles, and data associated with human performance capabilities and limitations
• Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices
• Experience with user-centered design methods
• Experience with conducting formative and summative usability evaluations, including study moderation
• Ability to direct and mentor junior staff

The Sr. Human Factors Engineer's responsibilities will be:

• Author, review, and edit Human Factors engineering documentation related to assigned projects. This includes research protocols, research reports, Usability Engineering plans, Use-Related Risk Analyses, and other design control documentation.
• Support continuous improvement initiatives to strengthen Human Factors practices and documentation.
• Work cross functionally with the core team to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
• Ensure our client's Human Factors Engineering process follows compliance within FDA recognized guidance and standards including IEC-62366, HE75, and others.
• Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and the validation of medical devices.
• Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
• Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices.
• Participate in the development of product requirements and evaluation of risks related to product use (risk analysis)

Compensation:

• $60.00 - $76.66/Hour