Sr. Human Factors Engineer II

Job Description

Sr. Human Factors Engineer II

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life threatening diseases.

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

• Develop human factors engineering (HFE) strategies and lead/support HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market. This includes ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.

• Author HF deliverables for device design history files. Writing HF sections for health authority submissions and written responses.

• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.

• Educate team members, and other internal stakeholders, on the HFE development process and approach.

• Interface and coordinate with HF consulting firms to execute human factors engineering activities.

• Improve internal HFE processes at Gilead to ensure consistency, compliance and efficiency

• Ensure all human factors engineering work is performed in accordance with SOPs and applicable regulatory requirements.

Required Education, Experience & Skills:

• A B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 8+ years of relevant experience, OR a M.S. degree with 6+ years of relevant experience.

• Experience with leading human factors engineering 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 well-defined and established procedures and policies in order to determine and take appropriate action.

• A deep knowledge of the regulatory and compliance requirements for human factors engineering and combination product risk management.

• Ability to effectively collaborate with cross-functional teams and influence key stakeholders.