Sr Human Factors Engineer I jobs in United States
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Gilead Sciences · 1 day ago

Sr Human Factors Engineer I

Gilead Sciences is dedicated to creating a healthier world for all people, focusing on tackling major diseases through innovative therapies. The Sr Human Factors Engineer I will lead and support human factors engineering strategies for device combination product design and development, ensuring compliance with regulatory requirements and improving internal processes.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Human Factors EngineeringCombination Product DevelopmentRegulatory ComplianceRisk ManagementData AnalysisDocument WritingInterpersonal CommunicationTeam Collaboration

Required

B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience
M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 4+ years of relevant experience
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

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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Company data provided by crunchbase