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Senior Device Engineer III - San Mateo, CA, United States - GILEAD Sciences
Description
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 DescriptionGilead 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 qualified Senior Device Engineer II to drive commercial readiness and life cycle management of drug-device combination products.
This individual will be responsible for supporting manufacturability assessments, design verification builds, clinical builds, and design transfer and commercialization activities.
This role requires expertise in design controls, process development, product/technology transfer, and process validation.Role and Responsibilities:
Independently manage technical issues with legacy device components of combination products to ensure supply chain continuity.
Lead device process engineering efforts on late-stage device project teams and Commercial CMC teams.
Manage manufacturability assessments on the product during early design and development.
Manage design verification and clinical product manufacturing builds.
Support manufacturing site selection activities.
Perform risk management per ISO 14971.Lead design transfer to internal and external manufacturing sites, executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents.
Manage commercial change controls and support complaints handling/investigations and deviations.Knowledge & SkillsDeep experience running multifunctional teams to manage technical issues at contract manufacturing organizations.
Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
Experience with design, execution, and statistical analysis of process characterization studies.
Execution of root cause analysis, deviation management, and investigation.
Experience working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.
Strong verbal, written, and interpersonal communication skills are required.
Must be able to write clear, concise, and error-free documents.
Basic Qualifications:
A Bachelor's Degree in mechanical engineering, chemical engineering, biomedical engineering, material science, or a related scientific field and a minimum of ten (10) years of relevant industry experience, OR a Master's Degree and a minimum of eight (8) years of relevant industry experience, OR a PhD and a minimum of two (2) years of experience.
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:
$172, $223, 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:
For jobs in the United States:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company.
Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
SummaryLocation:
United States - California - Foster CityType: Full time
