Device Engineer II

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 motivated and detailoriented Device Engineer II for our Foster City CA location to support the development and testing of Medical Devices and Combination Products (e.g. autoinjectors prefilled syringes needle safety systems copackaged kits). This role focuses on executing device testing supporting method development and partnering crossfunctionally to advance programs from early development through commercialization.

Responsibilities:

• Contribute to development activities across the device lifecycle from concept through commercialization.
• Support technical evaluation plans including handson laboratory testing and oversight of contract lab activities.
• Assist in developing optimizing and executing device test methods and characterization studies; support method validation with growing independence.
• Perform and supervise benchlevel experiments ensuring highquality data and adherence to internal procedures.
• Collaborate on fixture tooling and prototype design using CAD and 3D printing.
• Support design verification testing and method transfers to external labs or manufacturing sites.
• Author technical documentation including test methods protocols reports design control content and regulatory submission materials.
• Support quality investigations CAPAs and change controls for device testing.
• Contribute to continuous improvement initiatives (e.g. 5S Kaizen).
• Communicate results troubleshoot issues and support technical alignment with Device Engineering CMC Quality Regulatory and external partners.
• Present findings and study outcomes clearly to project teams and stakeholders.

Knowledge and Skills

• Strong problemsolving abilities and independence in executing testing activities.
• Proficient technical writing skills.
• Working knowledge of design control principles medical device regulations and cGMP.
• Familiarity with statistical techniques (e.g. Gauge R&R normality testing ANOVA) and statistical software (e.g. JMP Minitab).

Basic Qualifications:

• Masters and 2 years of relevant experience OR
• Bachelors and 4 years of relevant experience

Preferred Qualifications:

• Handson experience with mechanical testing device characterization or method development.
• Experience with medical device testing including test method development validation and design verification.
• Proficiency with statistical tools and techniques (e.g. Gauge R&R normality testing data transformations sampling strategies ANOVA) and software (e.g. JMP Minitab).
• Experience using CAD software (e.g. SolidWorks OnShape) and 3D printing for fixture or prototype development.

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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