Device Engineer III

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 are seeking a highly motivated and detail-orientated Device Engineer III to lead testing activities as a subject matter expert for cross-functional project teams developing Medical Devices and Combination Products.

Job Description

The Device Engineer III will focus on lab operations management, test method development and characterization testing in Gilead’s device and packaging lab, management of test method development / validation and design verification at external testing labs, and execution method transfers for release testing.

Specific Responsibilities

• Design, conduct and supervise experiments in internal labs and at external contract testing facilities to support product development.
• Design and develop test fixtures and custom tooling using CAD software and 3D printing technologies.
• Author, review and approve technical documentation including design control documents, test methods, test method validation protocols / reports, and design verification protocols / reports.
• Lead and execute design verification activities, including development and validation of test methods for medical devices and combination products.
• Support method transfers between development test labs, design verification test labs, and clinical and commercial manufacturing sites.
• Manage and maintain internal laboratory operations, ensuring compliance with 5S, Kaizen, and other continuous improvement methodologies.
• Collaborate cross-functionally to support regulatory submissions.
• Support testing-related product quality investigations, CAPAs, and change control activities.
• Communicate technical findings and project updates clearly to project teams and stakeholders.

Knowledge & Skills

Required Education & Experience

Preferred Experience

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

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.

#J-18808-Ljbffr