Job Description

Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.

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. 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.

Required Education:

B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 10+ years of relevant experience.

OR

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

Experience & Skills:

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.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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