Senior Human Factors Engineer / Senior Human Factors Engineeress

Sr. Human Factors Engineer - Contract - Remote - US

Imagine applying your Human Factors expertise to enhance patient outcomes and influence the future of healthcare technology. Proclinical has partnered with our client to offer an exciting opportunity for an experienced Senior Human Factors Engineer. Join a collaborative team dedicated to the development of innovative healthcare technologies. This role focuses on applying human factors expertise throughout the product lifecycle to ensure products are safe, effective, user-friendly, and compliant in a regulated environment.

Position Details

This position is remote, available to candidates within the United States.

Primary Responsibilities

• Apply Human Factors principles to the design, evaluation, and validation of innovative healthcare products and systems.
• Provide technical leadership throughout the product development process.
• Contribute to usability engineering activities and support regulatory compliance requirements.
• Identify user needs and risks, delivering safe and intuitive solutions that improve end-user outcomes.

Skills & Requirements

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

Competencies

• Deep expertise in effectively documenting Human Factors Engineering deliverables in the medical device industry.
• Experience with use-related risk analyses on medical devices.
• Strong background knowledge in diabetes and diabetes-care devices is preferred.
• Comprehensive understanding of FDA's Human Factors Guidance and recognized standards (HE75, IEC-62366) related to medical devices.
• Ability to apply Human Factors principles and methods to the design, evaluation, launch, and use of medical devices.
• Experience with user-centered design methods and conducting formative and summative usability evaluations.
• Ability to direct and mentor junior staff.

Responsibilities of the Sr. Human Factors Engineer

• Author, review, and edit Human Factors engineering documentation related to assigned projects.
• Support continuous improvement initiatives to enhance Human Factors practices and documentation.
• Collaborate cross-functionally to ensure comprehensive evaluation of use-related risks and appropriate risk controls are in place.
• Ensure compliance with FDA recognized guidance and standards, including IEC-62366, HE75, and others.
• Provide research and design inputs regarding human capabilities and product interactions.
• Create and conduct formative and summative studies to optimize medical device design and identify potential use errors.
• Analyze evaluation results and recommend improvements based on Human Factors guidelines and best practices.
• Participate in the development of product requirements and risk evaluations related to product use.

Compensation

$60.00 - $76.66/Hour

If you are interested in this exciting opportunity, please Apply online using the form below. Only applications matching the job profile will be considered.

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