Senior Device Engineer II

Senior Device Engineer II
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

The Device Engineering team at Gilead is seeking a qualified Senior Device Engineer II to drive commercial readiness and life cycle management of drug-device combination products.

This individual will be responsible for supporting manufacturability assessments, design verification builds, clinical builds, and design transfer and commercialization activities. This role requires expertise in design controls, process development, product/technology transfer, and process validation.

Job Responsibilities
Manage technical issues with legacy device components of combination products to ensure supply chain continuity.
Lead device process engineering efforts on late-stage device project teams and Commercial CMC teams.
Manage manufacturability assessments on the product during early design and development.
Manage design verification and clinical product manufacturing builds.
Support manufacturing site selection activities.
Perform risk management per ISO 14971.
Lead design transfer to internal and external manufacturing sites, executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents.
Manage commercial change controls and support complaints handling/investigations and deviations.

Knowledge & Skills
Deep experience running multifunctional teams to manage technical issues at contract manufacturing organizations.
Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
Experience with design, execution, and statistical analysis of process characterization studies.
Execution of root cause analysis, deviation management, and investigation.
Experience working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.
Strong verbal, written, and interpersonal communication skills are required.
Must be able to write clear, concise, and error-free documents.

Education & Experience
A Bachelor's Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of eight (8) years of relevant industry experience, OR
Master's Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of six (6) years of relevant industry experience OR
PhD in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of zero (0) years of relevant industry experience

The salary range for this position is: $154, $199, 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:

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

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 log onto your Internal Career Site to apply for this job.

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