Sr Human Factors Engineer II
Gilead Sciences
June 27, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Specific Job Responsibilities
- Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market (requirements definition, use-related risk analysis, formative usability studies, instruction/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 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 to ensure consistency, compliance, and efficiency.
- Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements.
Required Education
- B.S. degree in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 8+ years of relevant experience.
OR
- M.S. degree in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 6+ years of relevant experience.
Experience & Skills (Required)
- Leading HFE efforts for combination product development and commercialization; working knowledge of human factors, design controls, and risk management regulations/standards/guidance for medical devices and combination products.
- Excellent verbal, written, and interpersonal communication.
- Facilitate interfaces with medical device vendors and HF consulting firms.
- Analyze data to identify relevant design updates.
- Write clear, concise, high-quality documents.
- Exercise judgment in ambiguity and established procedures/policies.
- Manage team expectations for project timelines.
- Deep knowledge of regulatory/compliance requirements for HFE and combination product risk management.
- Collaborate cross-functionally and influence stakeholders.
- Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market (requirements definition, use-related risk analysis, formative usability studies, instruction/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 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 to ensure consistency, compliance, and efficiency.
- Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements.
Required Education
- B.S. degree in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 8+ years of relevant experience.
OR
- M.S. degree in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 6+ years of relevant experience.
Experience & Skills (Required)
- Leading HFE efforts for combination product development and commercialization; working knowledge of human factors, design controls, and risk management regulations/standards/guidance for medical devices and combination products.
- Excellent verbal, written, and interpersonal communication.
- Facilitate interfaces with medical device vendors and HF consulting firms.
- Analyze data to identify relevant design updates.
- Write clear, concise, high-quality documents.
- Exercise judgment in ambiguity and established procedures/policies.
- Manage team expectations for project timelines.
- Deep knowledge of regulatory/compliance requirements for HFE and combination product risk management.
- Collaborate cross-functionally and influence stakeholders.