Sr Device Engineer I

Gilead Sciences • Foster City, CA

2d

About The Position

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 skilled and proactive Senior Device Development Engineer to lead technical development efforts for parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This individual contributor role is ideal for an engineer with deep technical expertise, strong cross-functional collaboration skills, and a passion for delivering innovative, patient-centric solutions. The role may include oversight of contractors or matrixed resources but does not include direct people management.

Requirements

• Doctorate OR Master’s and 4+ years of relevant experience OR Bachelor’s and 6+ years of relevant experience OR

Nice To Haves

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
• Minimum of 6+ years (BS) or 4+ years (MS) of relevant experience in combination product development.
• Strong understanding of design control , risk management, and regulatory standards for combination products.
• Demonstrated ability to solve complex technical problems and contribute to strategic project decisions.
• Excellent communication and collaboration skills; able to work effectively across functions and with external partners.

Responsibilities

• Lead technical development activities for combination products from concept through commercialization, ensuring robust design and performance.
• Develop and execute design control documentation , including design inputs/outputs, verification, validation, and risk management.
• Author and review technical reports and contribute to regulatory submissions (IND, NDA, etc.).
• Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on development strategy and execution.
• Support technology transfer to clinical and commercial manufacturing sites, including process development and troubleshooting.
• Drive technical problem-solving , root cause analysis, and continuous improvement initiatives.
• Represent the device development function in internal and external technical discussions, including with suppliers and partners.
• Stay current with industry standards and regulatory expectations , including FDA, EMA, ISO 13485, ISO 14971, and cGMP.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees