Device Engineer III
Location: United States - California - Foster City
Remote Type: Onsite Required
Time Type: Full time
Job Description
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
Job Description
We are seeking a highly skilled and proactive Senior Device Engineer I to support testing, method development, design verification and method transfer activities for medical devices and parenteral combination products, including autoinjectors, prefilled syringes, and needle‑safety systems. This individual contributor role is ideal for an engineer with strong technical fundamentals, hands‑on testing experience, and the ability to collaborate effectively across development, quality, and manufacturing teams. The position sits within the Verification and Testing team supporting internal lab operations, design verification, external testing activities, and method transfer to manufacturing sites.
Job 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.
Basic Qualifications
Doctorate OR
Master’s and 3+ years of relevant experience OR
Bachelor’s and 5+ years of relevant experience
Preferred Qualifications
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.
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' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
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