Sr Device Engineer II
United States – California – Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The Device Development and Clinical Packaging Engineering department is seeking a self-driven and qualified Sr Device Engineer II to support the conceptualization, development, and commercialization of drug/device combination products. This individual will be responsible for the technical leadership of cross-functional project teams and the high-quality execution of feasibility, design control, and risk management deliverables. Qualified candidates should have experience and expertise in medical device/combination product development, design controls, risk management, design verification/validation, internal/external manufacturing, and working in a highly matrixed global environment. Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Job Responsibilities
- Lead cross-functional teams responsible for the development of drug delivery devices from initial concept generation through commercialization according to project timelines.
- Represent Device Development and provide device subject matter expertise in drug product development project teams.
- Develop and execute technical evaluation plans, conduct experiments on-site, and supervise experiments performed at contract sites.
- Author technical reports and Design History File / Risk Management File deliverables (Hazard Analysis, FMEA, Design Inputs, Specifications, Usability Task Analysis, V&V Protocols/Reports, etc.).
- Contribute to regulatory filing content related to combination products (IND, NDA, etc.).
- Support device product quality investigations, CAPAs and change control activities.
- Effectively communicate ideas, project goals, and results to team members and cross-functional leadership.
- Develops and implements continuous improvements to the Quality System and departmental best practices.
- Mentor engineers and other functional area team members in technical, regulatory, and compliance best practices and requirements.
- Foster highly collaborative, cross-functional relationships with stakeholders.
- Proactively resolve project obstacles and challenges
- Remain current, apply understanding, and mentor others in relevant FDA, ISO, and Quality System Requirements.
- Conduct other corporate duties as required.
Knowledge & Skills
- Completion of product development projects resulting in project transfer and commercialization
- Completion of post-market risk management activities
- Proven ability to lead and manage medical device / combination product development projects
- Proven ability to lead and manage multiple projects
- Development of design control and risk management deliverables per 21 CFR 820, ISO 13485, and ISO 14971
- Experience/knowledge with drug delivery systems and standards (ISO 11608, ISO 11040, etc.) is desired
- Completion of formative and summative usability assessments
- Experience in statistical analysis of complex data (distribution analysis, comparative analysis, ANOVA, regression)
- Excellent technical writing and communication skills
- Experience with project management methods and tools
- Experience working with external vendors, suppliers, and contract manufacturers
- Exercise judgement and high quality decision making within well-defined and established procedures and policies
Experience
- A Bachelor’s Degree in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of eight (8) years of relevant industry experience, OR a Master’s Degree in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of six (6) years of relevant industry experience, OR a PhD in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of zero (0) years of relevant industry experience.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
About Gilead: Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
The salary range for this position is: $149,600.00 – $193,600.00. 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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