Human Factors Engineering Lead - Associate Engineering Fellow

Objective:

Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF) is responsible for Human Centered Design of Medical Devices and Combination Products. The HFE Lead - AEF will be integral to design and development of product user interface including hardware, software, packaging, labeling, and instruction material to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment.

The HFE Lead responsibilities include but are not limited to:

• Leading and executing Human Factors strategy in compliance with regional regulatory guidance.
• Driving and overseeing User Research strategy in compliance with Quality Management System.
• Developing Human Factors Product and System level requirements in alignment with Target Product Profile.
• Conducting exploratory research to gather user insights and design trends and evaluate user interface concepts.
• Translating user needs into user experience and interface requirements and specifications.
• Designing and executing Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training.
• Conducting Task and Known Use Problem Analyses.
• Performing use-safety engineering through Use-related Risk Analysis.
• Developing Human Factors Validation Protocols and Reports.
• Managing Human Factors, Industrial Design, and User Research vendors.
• Supporting regulatory Human Factors Information Requests.
• Developing Human Factors Summary Reports in compliance with FDA guidance.
• Developing Usability Engineering Files in compliance with IEC and ISO standards.
• Leading development to Human Factors standard operating procedures and templates development.
• Applying functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
• Preparing documentation to support medical device and combination product development activities including design controls.
• Collaborating with cross functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines.
• Qualifying and managing Human Factors vendors.
• Supporting internal and external quality audits.
• Communicating with internal and external key stakeholders.
• Mentoring Human Factors Engineering Leads.

Education & Qualifications:

• Doctorate degree and 7 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• OR, Master's degree and 13 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• OR, Bachelor's degree and 15 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry

Physical Health Requirements:

• While the role of a Human Factors Engineering Lead primarily involves cognitive and analytical tasks, good physical health is essential. Engineers may need to visit manufacturing sites or conduct user testing in clinical environments, which might involve walking, standing, or other physical activities.
• Depending on the role and specific responsibilities, a Human Factors Engineering Lead may need to travel to clinical sites, supplier facilities, or other locations for research and testing purposes.

Travel Requirements:

This position may require up to 20% yearly travel, including domestic and international.