Sr Human Factors Engineer II

Role Summary

Sr Human Factors Engineer II at Gilead. Focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.

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. 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.

Qualifications

• 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 with leading HFE efforts in support of combination product development and commercialization, including knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.
• Demonstrated ability to facilitate interface with medical device vendors and HF consulting firms.
• Demonstrated ability to analyze data and identify relevant design updates; able to write clear, concise, high-quality documents; able to exercise judgment within areas of ambiguity and established procedures.
• Experience managing team expectations for project timelines, including realistic timeline estimates for HFE activities.
• 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.

Skills

• Experience leading HFE efforts in support of combination product development and commercialization.
• 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.
• Ability to facilitate interfaces with medical device vendors and HF consulting firms.
• Analytical capability to identify design updates from data and write high-quality documentation.
• Judgment in ambiguous situations and adherence to established procedures.
• Collaborative ability to work with cross-functional teams and influence stakeholders.

Education

• 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