Gilead Sciences · 1 day ago
Sr Device Engineer I
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$136K/yr - $176K/yr
4+ years expGilead Sciences is dedicated to creating a healthier world by tackling major diseases and developing life-changing therapies. They are seeking a Senior Device Development Engineer to lead the technical development of drug-device combination products, focusing on innovative solutions and cross-functional collaboration.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead technical development activities for combination products from concept through commercialization, ensuring robust design and performance
Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management
Author and review technical reports and contribute to regulatory submissions (IND, NDA, etc.)
Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on development strategy and execution
Support technology transfer to clinical and commercial manufacturing sites, including process development and troubleshooting
Drive technical problem-solving, root cause analysis, and continuous improvement initiatives
Represent the device development function in internal and external technical discussions, including with suppliers and partners
Stay current with industry standards and regulatory expectations, including FDA, EMA, ISO 13485, ISO 14971, and cGMP
Qualification
Required
Doctorate OR
Master's and 4+ years of relevant experience OR
Bachelor's and 6+ years of relevant experience OR
Lead technical development activities for combination products from concept through commercialization, ensuring robust design and performance
Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management
Author and review technical reports and contribute to regulatory submissions (IND, NDA, etc.)
Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on development strategy and execution
Support technology transfer to clinical and commercial manufacturing sites, including process development and troubleshooting
Drive technical problem-solving, root cause analysis, and continuous improvement initiatives
Represent the device development function in internal and external technical discussions, including with suppliers and partners
Stay current with industry standards and regulatory expectations, including FDA, EMA, ISO 13485, ISO 14971, and cGMP
Preferred
Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field
Minimum of 6+ years (BS) or 4+ years (MS) of relevant experience in combination product development
Strong understanding of design control, risk management, and regulatory standards for combination products
Demonstrated ability to solve complex technical problems and contribute to strategic project decisions
Excellent communication and collaboration skills; able to work effectively across functions and with external partners
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
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
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 CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-06
MarketScreener
2026-01-06
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