Gilead Sciences · 20 hours ago
Sr. Device Engineering I, Device Engineering
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$136K/yr - $176K/yr
4+ years expGilead Sciences is committed to creating a healthier world by developing therapies for serious diseases. They are seeking a Senior Device Engineer I to support testing, method development, design verification, and method transfer activities for medical devices and combination products.
BiotechnologyHealthcarePharmaceuticalManufacturingBiopharmaHealth Care
Responsibilities
Support design control activities, including design verification, design transfer and risk‑management deliverables
Develop, optimize, and validate test methods for device and combination‑product components
Execute design verification (DV) testing and prepare protocols, data summaries, and technical reports
Assist with method transfers between internal labs, external DV labs, and manufacturing sites
Coordinate and monitor external testing, ensuring methods, protocols, and data meet quality and compliance standards
Contribute to lab operations, including equipment readiness, sample coordination, and maintaining 5S/Kaizen practices
Support quality investigations (e.g., deviations, CAPAs, change controls) related to testing activities
Represent the Device Engineering function in internal meetings, supplier interactions, and project team forums
Communicate technical findings clearly with cross‑functional partners
Qualification
Required
Doctorate OR
Master's and 4+ years of relevant experience OR
Bachelor's and 6+ years of relevant experience
Preferred
Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field
Experience in combination product development, medical device testing, or pharmaceutical/biotech environments
Hands‑on experience with: Test method development and validation, Design verification testing, Characterization and performance testing for combination products
Understanding of design control, risk management, and regulatory standards (FDA, ISO 13485, ISO 14971, cGMP)
Familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369)
Experience with statistical techniques (e.g., ANOVA, Gauge R&R, sample size calculations) and statistical software (JMP, Minitab)
Strong communication skills, with the ability to write clear and concise technical documents
Demonstrated ability to troubleshoot, conduct root‑cause investigations, and drive continuous improvement
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
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