Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life‑threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
We are seeking a highly motivated and detail‑orientated
Device Engineer III
to lead testing activities as a subject matter expert for cross‑functional project teams developing medical devices and combination products (e.g., autoinjectors, pre‑filled syringes, needle safety devices, co‑packaged device kits). Qualified candidates will focus on 1) lab operations management, test method development and characterization testing in Gilead’s device and packaging lab; 2) management of test method development/validation and design verification at external testing labs; and 3) execution of method transfers for release testing.
Specific Responsibilities
Design, conduct and supervise experiments in internal labs and at external contract testing facilities to support product development.
Design and develop test fixtures and custom tooling using CAD software (e.g., Solidworks, OnShape) and 3D printing technologies.
Author, review and approve technical documentation including design control documents, test methods, test method validation protocols/reports, and design verification protocols/reports.
Lead and execute design verification activities, including development and validation of test methods for medical devices and combination products.
Support method transfers between development test labs, design verification test labs, and clinical and commercial manufacturing sites.
Manage and maintain internal laboratory operations, ensuring compliance with 5S, Kaizen, and other continuous improvement methodologies.
Collaborate cross‑functionally to support regulatory submissions (e.g., IND, NDA, BLA).
Support testing‑related product quality investigations, CAPAs, and change control activities.
Communicate technical findings and project updates clearly to project teams and stakeholders.
Knowledge & Skills
Strong verbal, written, and interpersonal communication skills.
Ability to write clear, concise, and error‑free documents.
Ability to exercise judgment within established procedures and policies in order to determine and take appropriate action.
Self‑motivated and organized, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Basic Qualifications
Master’s and 3+ years of relevant experience OR
Bachelor’s and 5+ years of relevant experience OR
Preferred Qualifications
Hands‑on experience with medical device testing and development, particularly in test method development, test method validation, and design verification.
Familiarity with FDA regulations, cGMP standards, and design control for medical devices.
Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA).
Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369).
Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development.
Demonstrated success implementing 5S/Kaizen or other continuous improvement practices.
Experience with technology transfer and scale‑up of combination product testing methods.
Experience with statistical software (e.g., JMP, Minitab).
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We are seeking a highly motivated and detail‑orientated
Device Engineer III
to lead testing activities as a subject matter expert for cross‑functional project teams developing medical devices and combination products (e.g., autoinjectors, pre‑filled syringes, needle safety devices, co‑packaged device kits). Qualified candidates will focus on 1) lab operations management, test method development and characterization testing in Gilead’s device and packaging lab; 2) management of test method development/validation and design verification at external testing labs; and 3) execution of method transfers for release testing.
Specific Responsibilities
Design, conduct and supervise experiments in internal labs and at external contract testing facilities to support product development.
Design and develop test fixtures and custom tooling using CAD software (e.g., Solidworks, OnShape) and 3D printing technologies.
Author, review and approve technical documentation including design control documents, test methods, test method validation protocols/reports, and design verification protocols/reports.
Lead and execute design verification activities, including development and validation of test methods for medical devices and combination products.
Support method transfers between development test labs, design verification test labs, and clinical and commercial manufacturing sites.
Manage and maintain internal laboratory operations, ensuring compliance with 5S, Kaizen, and other continuous improvement methodologies.
Collaborate cross‑functionally to support regulatory submissions (e.g., IND, NDA, BLA).
Support testing‑related product quality investigations, CAPAs, and change control activities.
Communicate technical findings and project updates clearly to project teams and stakeholders.
Knowledge & Skills
Strong verbal, written, and interpersonal communication skills.
Ability to write clear, concise, and error‑free documents.
Ability to exercise judgment within established procedures and policies in order to determine and take appropriate action.
Self‑motivated and organized, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Basic Qualifications
Master’s and 3+ years of relevant experience OR
Bachelor’s and 5+ years of relevant experience OR
Preferred Qualifications
Hands‑on experience with medical device testing and development, particularly in test method development, test method validation, and design verification.
Familiarity with FDA regulations, cGMP standards, and design control for medical devices.
Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA).
Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369).
Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development.
Demonstrated success implementing 5S/Kaizen or other continuous improvement practices.
Experience with technology transfer and scale‑up of combination product testing methods.
Experience with statistical software (e.g., JMP, Minitab).
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