Sr Human Factors Engineer II

Sr Human Factors Engineer II

Location:

United States - California - Foster City – Regular

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID‑19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations.

We’re looking for passionate and ambitious people ready to make a direct impact.

• 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, including 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 mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 8+ years of relevant experience.
• OR M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience.

• Experience leading HFE efforts in support of combination product development and commercialization, with 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 the interface with medical device vendors and HF consulting firms.
• Demonstrated ability to analyze data and identify relevant design updates.
• Must be able to write clear, concise, high‑quality documents.
• Must exercise judgment within areas of ambiguity and 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 the regulatory and compliance requirements for HFE and combination product risk management.
• Ability to collaborate with cross‑functional teams and influence key stakeholders.

The salary range for this position is: $ - $. This position may also 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*.

For additional benefits information, visit:

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

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 environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.