Director, Device Engineering

Director, Device Engineering

United States - California - Foster City Manufacturing Operations & Supply Chain Regular

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

Specific

Job Responsibilities

Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function.

Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance.

Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management.

Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes.

Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO.

Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations.

Required Education & Experience

Bachelor's Degree and Twelve Years’ Experience

OR

Masters' Degree and Ten Years’ Experience

OR

PhD and Eight Years’ Experience

Preferred Experience

Experience leading combination product development projects and managing device engineers .

A Bachelor’s Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master’s Degree and a minimum of eight (8) years of relevant industry.

Experience with the development and commercialization of combination products.

Working knowledge of FDA, EMA, and cGMP standards for combination products.

Strong verbal, written, and interpersonal communication skills .

Able to write clear, concise, and error-free documents.

Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.

People Leader Accountabilities:

Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

Job Description

At Gilead, we’re creating a…