Senior Human Factors Engineer II

Senior Human Factors Engineer II
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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 AstraZeneca 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 guidances 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 takeappropriate 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.

The salary range for this position is: $154, $199, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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