About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered therapies for some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. The company's relentless drive in oncology, inflammatory diseases, and infectious diseases has resulted in life-changing innovations that improve patient outcomes and ensure global access to treatments. Headquartered in Foster City, California, Gilead fosters a collaborative environment where every team member contributes to bold scientific advancements. With a focus on employee empowerment and inclusive leadership, Gilead is the place where ambitious professionals make a direct impact on global health.

Role Overview

The Sr Human Factors Engineer II position at Gilead Sciences in Foster City, California, is a pivotal role in the development of drug-device combination products, such as pre-filled syringes and auto-injectors. This full-time position involves leading human factors engineering (HFE) strategies from early feasibility through clinical development, registration, and post-market surveillance. As a key player in Gilead's device development team, you will ensure user-centered design that meets stringent regulatory standards, enhancing patient safety and usability. This role offers the chance to work on groundbreaking therapies in HIV, oncology, and inflammatory diseases, combining technical expertise with cross-functional collaboration in a premium biotech environment.

Why Human Factors Engineering at Gilead?

Human factors engineering is critical in biopharma for combination products, where device usability directly impacts therapy efficacy and patient adherence. At Gilead, you'll apply HFE to real-world challenges, mitigating use-related risks and optimizing designs for diverse user populations.

Key Responsibilities

In this senior role, you will drive HFE activities across the product lifecycle. Responsibilities include leading or supporting HFE strategies, defining requirements, performing use-related risk analyses, developing instructions and training materials, and executing formative and summative usability studies. You will author essential HFE deliverables for design history files and regulatory submissions, educate internal stakeholders on HFE processes, and interface with consulting firms. Additionally, you'll enhance Gilead's internal HFE processes for consistency, compliance, and efficiency, all while adhering to SOPs and regulations like IEC 62366 and FDA guidance on human factors.

Qualifications & Requirements

Candidates must hold a B.S. in mechanical engineering, chemical engineering, bioengineering, or a related field with at least 8 years of relevant experience, or an M.S. with 6+ years. Proven experience leading HFE for combination product development and commercialization is essential, including deep knowledge of human factors standards, design controls, and risk management for medical devices. Excellent verbal, written, and interpersonal skills are required, along with the ability to analyze data, facilitate vendor interactions, and manage project timelines. You should thrive in ambiguity, influence cross-functional teams, and ensure compliance with regulatory requirements.

Preferred Experience

Ideal candidates have managed HFE for auto-injectors or syringes, authored submission documents, and improved processes in a pharma setting. A track record of realistic timeline estimation and stakeholder education sets top performers apart.

Benefits & Perks

Gilead Sciences offers a competitive salary range of $157,590 to $203,940, determined by experience, qualifications, and location. Beyond compensation, enjoy comprehensive health benefits, retirement plans, and wellness programs. Gilead invests in your growth with training, mentorship, and leadership development. The Foster City campus provides state-of-the-art facilities, flexible work options, and a culture of inclusion where every employee feels empowered. Additional perks include generous PTO, stock options, and access to cutting-edge therapies shaping HIV treatment, oncology breakthroughs, and inflammatory disease management.

Career Growth

At Gilead, career progression is a priority. As a Sr Human Factors Engineer II, you'll have opportunities to lead larger projects, mentor juniors, and transition into people leadership roles. Gilead's commitment to evolving culture supports aspirations in technical expertise or management. With exposure to global regulatory submissions and cross-functional teams, you'll build a robust network in biopharma, positioning yourself for director-level roles in device development or beyond.

Why Join Gilead

Joining Gilead means contributing to therapies that combat HIV, advance oncology, and address inflammatory diseases, impacting millions worldwide. In Foster City, you'll collaborate with top talent in a supportive environment that values determination and innovation. Gilead's mission-driven culture, combined with premium benefits and growth opportunities, makes it an ideal place for HFE experts passionate about patient-centric design. Be part of creating possible—together.

Role FAQs

Q: What is the experience level required? A: B.S. +8 years or M.S. +6 years in relevant HFE for combination products.

Q: Is leadership experience necessary? A: Yes, experience leading HFE efforts and managing timelines is key.

Q: What regulations apply? A: FDA human factors guidance, IEC 62366, ISO 14971 for risk management.

Q: Is relocation support available? A: Gilead offers competitive packages; inquire during application.

Q: How does this role impact Gilead's pipeline? A: Directly supports device combos for HIV, cancer, and inflammation therapies.