Sr Human Factors Engineer I

* 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.* Experience with leading HFE efforts in support of combination product development and commercialization, including a 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 are required.* 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 be able to exercise judgment within areas of ambiguity as well as established procedures and policies in order 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 effectively collaborate with cross-functional teams and influence key stakeholders. #J-18808-Ljbffr