Sr Human Factors Engineer II at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 8+ years of relevant experience OR M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience
Experience leading HFE efforts in support of combination product development and commercialization
Working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products

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, including 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

Skills

Key technologies and capabilities for this role

Human Factors EngineeringUsability TestingUser Experience DesignHuman-Computer InteractionRisk AnalysisMedical Device Design

Questions & Answers

Common questions about this position

What is the salary range for the Sr Human Factors Engineer II position?

This information is not specified in the job description.

Is this a remote position, or is there a required office location?

This information is not specified in the job description.

What are the main responsibilities for this Sr Human Factors Engineer II role?

Responsibilities include leading or supporting human factors engineering strategies and activities for device combination products from feasibility through post-market, such as requirements definition, use-related risk analysis, formative and summative usability studies, instruction development, and authoring HFE deliverables for design history files and health authority submissions.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with every employee playing a critical role in scientific innovations. They focus on strong people leadership to create an inclusive, developmental environment where employees feel empowered.

What kind of experience makes a strong candidate for this role?

Strong candidates will have experience focusing on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors, along with expertise in human factors engineering activities throughout the product lifecycle.

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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