Gilead Sciences
Assoc Director, Device Engineering
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Assoc Director, Device Engineering role at Gilead Sciences. We are seeking a people-focused and technically strong individual to lead a team of engineers in the design and development of parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This is a first-line people manager position responsible for developing talent, fostering a collaborative and high-performing team culture, and ensuring successful execution of device development programs. Key Responsibilities
Lead, manage, and develop a team of engineers, providing coaching, performance feedback, and career development support. Foster a culture of collaboration, accountability, and continuous improvement within the device development function. Oversee technical execution of combination product development programs, ensuring alignment with design control and regulatory requirements. Ensure high-quality documentation, including design inputs/outputs, verification, validation, and risk management deliverables. Contribute to regulatory submissions, including INDs, NDAs, and other global filings. Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on strategy, timelines, and risk mitigation. Support technology transfer to clinical and commercial manufacturing sites. Drive problem-solving and root cause analysis for product quality investigations and change control activities. Represent the team and function in internal and external meetings, including with suppliers and partners. Basic Qualifications
Doctorate and 5+ years of relevant experience OR Masters and 8+ years of relevant experience OR Bachelors and 10+ years of relevant experience Preferred Qualifications
Bachelors or Masters degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Minimum of 10+ years (BS) or 8+ years (MS) of relevant industry experience in combination product development. Prior experience managing or mentoring engineers in a technical environment is required. Strong understanding of design control, risk management, and regulatory standards (FDA, EMA, ISO 13485, ISO 14971, cGMP). Proven ability to lead teams, manage performance, and build a positive team culture. Excellent communication and interpersonal skills; able to influence across functions and levels. Demonstrated ability to solve complex problems and make decisions aligned with organizational goals. Compensation and Benefits
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. 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 Equal Employment Opportunity
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 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 prohibited grounds under applicable laws. Reasonable accommodations are available upon request. Please apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr
Assoc Director, Device Engineering role at Gilead Sciences. We are seeking a people-focused and technically strong individual to lead a team of engineers in the design and development of parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This is a first-line people manager position responsible for developing talent, fostering a collaborative and high-performing team culture, and ensuring successful execution of device development programs. Key Responsibilities
Lead, manage, and develop a team of engineers, providing coaching, performance feedback, and career development support. Foster a culture of collaboration, accountability, and continuous improvement within the device development function. Oversee technical execution of combination product development programs, ensuring alignment with design control and regulatory requirements. Ensure high-quality documentation, including design inputs/outputs, verification, validation, and risk management deliverables. Contribute to regulatory submissions, including INDs, NDAs, and other global filings. Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on strategy, timelines, and risk mitigation. Support technology transfer to clinical and commercial manufacturing sites. Drive problem-solving and root cause analysis for product quality investigations and change control activities. Represent the team and function in internal and external meetings, including with suppliers and partners. Basic Qualifications
Doctorate and 5+ years of relevant experience OR Masters and 8+ years of relevant experience OR Bachelors and 10+ years of relevant experience Preferred Qualifications
Bachelors or Masters degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Minimum of 10+ years (BS) or 8+ years (MS) of relevant industry experience in combination product development. Prior experience managing or mentoring engineers in a technical environment is required. Strong understanding of design control, risk management, and regulatory standards (FDA, EMA, ISO 13485, ISO 14971, cGMP). Proven ability to lead teams, manage performance, and build a positive team culture. Excellent communication and interpersonal skills; able to influence across functions and levels. Demonstrated ability to solve complex problems and make decisions aligned with organizational goals. Compensation and Benefits
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. 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 Equal Employment Opportunity
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 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 prohibited grounds under applicable laws. Reasonable accommodations are available upon request. Please apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr