Director, Device Engineering
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 DescriptionThe Device Engineering team at Gilead is seeking an experienced Director of Device Engineering to lead commercial readiness and oversee the lifecycle management of drug–device combination products. This individual will be responsible for leading cross-functional teams to establish new manufacturing sites and successfully commercialize innovative products.
The ideal candidate will possess deep expertise in program team leadership, design controls, process development, new product introduction, design transfer, and process validation.
Job Responsibilities
- Lead cross-functional programs to define and implement design/technology transfer strategies for both internal and external manufacturing sites.
- Lead project teams to harmonize control strategy practices within device development.
- Manage design control remediation projects across multiple products, including implementing harmonized risk management for legacy products in accordance with ISO 14971.
- Lead cross-functional teams to complete design transfers to manufacturing sites.
- Drive quality and business process improvement initiatives.
- Manage contractors and provide mentorship to junior engineers.
- Provide technical support for manufacturing site selection activities.
Basic Qualifications:
- Doctorate and 8+ years of relevant experience OR
- Master’s and 10+ years of relevant experience OR
- Bachelor’s and 12+ years of relevant experience OR
Preferred Qualifications:
- Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field
- Extensive experience in prefilled drug delivery device development and commercialization, with specialization in assembly characterization and design transfer.
- Proven track record in managing multifunctional teams and executing transfers to internal and external manufacturing sites.
- Skilled in collaborating with equipment vendors and manufacturers, including creating RFPs, developing user requirements, and qualifying equipment.
- Proficient in the design, execution, and statistical analysis of process characterization studies.
- Experienced in root cause investigations and deviation management.
- Strong verbal, written, and interpersonal communication skills.
- Ability to produce clear, concise, and error-free documentation.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
For additional benefits information, visit:
* 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.
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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