Assoc Director, Human Factors Engineering and Human-Centered Design Specialist

Assoc Director, Human Factors Engineering and Human-Centered Design Specialist Overview

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. We are focused on developing therapies to address unmet medical needs and improve lives. The role focuses on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.

• Support innovation and early-stage development, helping drive project strategy based on human-centered design and human factors principles and methodologies.
• Lead initiatives to advance human-centered design practices within the organization.
• Conduct qualitative and quantitative user research to gather insights on user needs, preferences, and behaviors. Analyze research findings to identify opportunities for product and user experience improvement and innovation. Present research findings to stakeholders and provide actionable recommendations.
• Develop and implement design strategies that prioritize user experience and accessibility, including creating personas, journey maps, and simulations to inform design decisions based on a deep and data-based understanding of the user experience and user needs.
• Develop design concepts for devices, packaging, and instructions and create concept sketches, illustrations, and prototypes.
• Use visual design principles to create instructional materials that are visually appealing and effective in conveying information and supporting safe and effective use of products.
• Lead or support human factors engineering (HFE) strategies and activities for device combination product design and development from feasibility, clinical development, through registration, and post-market. This includes requirements definition, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.
• Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses.
• Educate team members and other internal stakeholders on the HFE development process and approach.
• Interface and coordinate with HFE consulting firms to execute human factors engineering activities.
• Improve internal HFE processes at Gilead to ensure consistency, compliance, and efficiency.
• Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements.

• B.S. degree in biomedical engineering, industrial design, or a related scientific field with 10+ years of relevant experience, OR a M.S. degree with 8+ years of relevant experience.
• Strong understanding of human-centered design principles and user research methodologies.
• Experience with conducting qualitative and quantitative user research.
• Proficiency in design tools (e.g., Adobe Creative Suite).
• Prototyping skills, including the ability to create physical and digital prototypes.
• Expertise in visual design principles, including layout, typography, and color theory.
• Experience with leading HFE efforts in support of combination product development and commercialization, including working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrated ability to facilitate interfaces with medical device vendors and HF consulting firms.
• Demonstrated ability to analyze data and identify relevant design updates.
• Ability to write clear, concise, high-quality documents.
• Ability to exercise judgment within areas of ambiguity as well as established procedures and policies to determine and take appropriate action.
• Experience managing team expectations for project timelines, including realistic timeline estimates for HFE activities.
• A deep knowledge of regulatory and compliance requirements for HFE and combination product risk management.
• Ability to effectively collaborate with cross-functional teams and influence key stakeholders.

The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Eligible employees may participate in benefit plans subject to plan terms. For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work…