Sr Human Factors Engineer

Position: 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.
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