Getting Hired
Overview
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 continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description
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 (e.g., autoinjectors, pre-filled syringes, needle safety devices, co-packaged device kits). Qualified candidates will focus on 1) lab operations management, test method development and characterization testing in Gilead’s device and packaging lab; 2) management of test method development / validation and design verification at external testing labs; and 3) 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 (e.g., Solidworks, OnShape) 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 (e.g., IND, NDA, BLA). 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
Strong verbal, written, and interpersonal communication skills. Ability to write clear, concise, and error-free documents. Ability to exercise judgment within established procedures and policies in order to determine and take appropriate action. Self-motivated and organized, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions. Required Education & Experience
Bachelor’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 master’s degree in the same fields with a minimum of four (4) years of relevant industry experience (e.g., pharma, biotech, medical devices). Hands-on experience with medical device testing and development, particularly in test method development, test method validation, and design verification. Familiarity with FDA regulations, cGMP standards, and design control for medical devices. Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA). Preferred Experience
Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369). Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development. Demonstrated success implementing 5S/Kaizen or other continuous improvement practices. Experience with technology transfer and scale-up of combination product testing methods. Experience with statistical software (e.g., JMP, Minitab). 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. (Link omitted for formatting.) 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: $117,895.00 - $152,570.00. 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, 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. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Our 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 opinions. Please apply via the Internal Career Opportunities portal in Workday.
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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 continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description
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 (e.g., autoinjectors, pre-filled syringes, needle safety devices, co-packaged device kits). Qualified candidates will focus on 1) lab operations management, test method development and characterization testing in Gilead’s device and packaging lab; 2) management of test method development / validation and design verification at external testing labs; and 3) 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 (e.g., Solidworks, OnShape) 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 (e.g., IND, NDA, BLA). 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
Strong verbal, written, and interpersonal communication skills. Ability to write clear, concise, and error-free documents. Ability to exercise judgment within established procedures and policies in order to determine and take appropriate action. Self-motivated and organized, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions. Required Education & Experience
Bachelor’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 master’s degree in the same fields with a minimum of four (4) years of relevant industry experience (e.g., pharma, biotech, medical devices). Hands-on experience with medical device testing and development, particularly in test method development, test method validation, and design verification. Familiarity with FDA regulations, cGMP standards, and design control for medical devices. Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA). Preferred Experience
Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369). Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development. Demonstrated success implementing 5S/Kaizen or other continuous improvement practices. Experience with technology transfer and scale-up of combination product testing methods. Experience with statistical software (e.g., JMP, Minitab). 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. (Link omitted for formatting.) 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: $117,895.00 - $152,570.00. 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, 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. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Our 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 opinions. Please apply via the Internal Career Opportunities portal in Workday.
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