Description

The Device Engineering team at Gilead is seeking a qualified Associate Director of Device Engineering to drive commercial readiness and manage the life cycle of drug-device combination products. This individual will be responsible for leading cross functional teams to establish new manufacturing sites and commercialize new products. Expertise in design controls, process development, new product introduction, design transfer, and process validation is essential. Job Responsibilities Lead cross-functional team to complete design transfer to internal and external manufacturing sites – including executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents. Lead product and / or process improvement projects. Lead quality and business process improvement projects. Mentor junior engineers. Manage technical issues with legacy device components of combination products to ensure supply chain continuity. Provide technical support for manufacturing site selection activities. Implement harmonized risk management for legacy products per ISO 14971. Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master’s and 8+ years of relevant experience OR Bachelor’s and 10+ years of relevant experience OR Preferred Qualifications: Expertise running multifunctional teams and managing technical issues at contract manufacturing organizations. Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements. Expertise working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment. Experience with design, execution, and statistical analysis of process characterization studies. Execution of root cause analysis, deviation management, and investigation. Strong verbal, written, and interpersonal communication skills are required. Must be able to write clear, concise, and error-free documents. The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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: * 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 for assistance.