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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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 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.

Required Education** **&** **Experience

+ Bachelor’s degree in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of six (6) years of relevant industry experience OR a master’s degree in the same fields with a minimum of four (4) years of relevant industry experience (e.g., pharma, biotech, medical devices).

+ 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).

Preferred Experience

+ 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).

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO\_Cg

About Gilead

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.

The salary range for this position is: $117,895.00 - $152,570.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.