Gilead Sciences
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. Position
Sr. Human Factors Engineer I Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors. Specific Responsibilities
Lead or support human factors engineering (HFE) strategies and activities for device combination product design and development from feasibility, through clinical development, registration, and post-market. This includes requirements definition, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies. Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses. Educate team members and other internal stakeholders on the HFE development process and approach. Interface and coordinate with HFE consulting firms to execute human factors engineering activities. Improve internal HFE processes at Gilead to ensure consistency, compliance, and efficiency. Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements. Education
B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience OR M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 4+ years of relevant experience Experience & Skills
Experience leading HFE efforts in support of combination product development and commercialization, with working knowledge of human factors, design controls, risk management regulations, standards, and guidance for medical devices and combination products. Excellent verbal, written, and interpersonal communication skills. Ability to facilitate interfaces with medical device vendors and HF consulting firms. Ability to analyze data and identify design updates; ability to write clear, concise, high-quality documents. Judgment in areas of ambiguity and in following established procedures and policies. Experience managing project timelines and providing realistic timeline estimates for HFE activities. Deep knowledge of regulatory and compliance requirements for HFE and combination product risk management. Ability to collaborate with cross-functional teams and influence key stakeholders. People Leader Accountabilities
Create Inclusion - model and embed the value of diversity in team management. Develop Talent - coach employees on performance and potential; support their growth. Empower Teams - align goals and objectives, remove barriers, and connect teams to the broader organization. Compensation and Benefits
Salary range for this position is $136,340.00 - $176,440.00. Gilead considers a variety of factors when determining base compensation, including experience and location. Actual compensation may vary. This position may 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 Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other non-job related characteristics or prohibited grounds under applicable laws. Reasonable accommodation for individuals protected by law can be requested via ApplicantAccommodations@gilead.com. Other notices include notices for the Family and Medical Leave Act, pay transparency, and related protections. We promote a work environment free of harassment and celebrate diversity of thoughts and backgrounds. How to Apply
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. Position
Sr. Human Factors Engineer I Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors. Specific Responsibilities
Lead or support human factors engineering (HFE) strategies and activities for device combination product design and development from feasibility, through clinical development, registration, and post-market. This includes requirements definition, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies. Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses. Educate team members and other internal stakeholders on the HFE development process and approach. Interface and coordinate with HFE consulting firms to execute human factors engineering activities. Improve internal HFE processes at Gilead to ensure consistency, compliance, and efficiency. Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements. Education
B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience OR M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 4+ years of relevant experience Experience & Skills
Experience leading HFE efforts in support of combination product development and commercialization, with working knowledge of human factors, design controls, risk management regulations, standards, and guidance for medical devices and combination products. Excellent verbal, written, and interpersonal communication skills. Ability to facilitate interfaces with medical device vendors and HF consulting firms. Ability to analyze data and identify design updates; ability to write clear, concise, high-quality documents. Judgment in areas of ambiguity and in following established procedures and policies. Experience managing project timelines and providing realistic timeline estimates for HFE activities. Deep knowledge of regulatory and compliance requirements for HFE and combination product risk management. Ability to collaborate with cross-functional teams and influence key stakeholders. People Leader Accountabilities
Create Inclusion - model and embed the value of diversity in team management. Develop Talent - coach employees on performance and potential; support their growth. Empower Teams - align goals and objectives, remove barriers, and connect teams to the broader organization. Compensation and Benefits
Salary range for this position is $136,340.00 - $176,440.00. Gilead considers a variety of factors when determining base compensation, including experience and location. Actual compensation may vary. This position may 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 Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other non-job related characteristics or prohibited grounds under applicable laws. Reasonable accommodation for individuals protected by law can be requested via ApplicantAccommodations@gilead.com. Other notices include notices for the Family and Medical Leave Act, pay transparency, and related protections. We promote a work environment free of harassment and celebrate diversity of thoughts and backgrounds. How to Apply
Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr