Director, Human Factors Engineering and Human-Centered Design Specialist

Director, Human Factors Engineering and Human-Centered Design Specialist

Director, Human Factors Engineering and Human-Centered Design Specialist

United States - California - Foster City Manufacturing Operations & Supply Chain Regular

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

The Device, Packaging and Process (DPP) function is a key component of Gileads Pharmaceutical Development and Manufacturing (PDM) organization, providing a portfolio of technologies for selection and implementation by product teams. These technologies enable product teams to develop and execute a strategy to differentiate our products and ensure Gilead is highly competitive in commercial markets. As the Director, Human Factors Engineering and Human-Centered Design Specialist you will support innovation and early-stage development, helping drive project strategy based on human centered design and human factors principles and methodologies as well as lead initiatives to advance human-centered design practices within the organization.

Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.

Specific Job Responsibilities

Conduct qualitative and quantitative user research to gather insights on user needs, preferences, and behaviors. Analyze research findings to identify opportunities for product and user experience improvement and innovation. Present research findings to stakeholders and provide actionable recommendations.

Develop and implement design strategies that prioritize user experience and accessibility, including creating personas, journey maps, and simulations to inform design decisions based on a deep and data-based understanding of the user experience and user needs.

Develop design concepts for devices, packaging, and instructions and create concept sketches, illustrations, and prototypes.

Use visual design principles to create instructional materials that are visually appealing and effective in conveying information and supporting safe and effective use of products.

Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through 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.

Required Education, Experience & Skills :

A Bachelors degree in biomedical engineering, industrial design, or a related scientific field with 12+ years of relevant experience, OR a M.S. degree with 10+ years of relevant experience

Strong understanding of human-centered design principles and user research methodologies.

Experience with conducting qualitative and quantitative user research.

Proficiency in design tools (e.g., Adobe Creative Suite).

Prototyping skills, including the ability to create physical and digital prototypes.

Expertise in visual design principles, including layout, typography, and color theory.

Ex p eri e nc e w i th leading HFE efforts in support of combination product development and commercialization, including a working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.

Excellent v erb al , wri tt e n, a nd in terper s o na l c o mm u nic at io n skill s are r e quir e d .

Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms .

Demonstrated ability to analyze data and identify relevant design updates.

M us t b e a bl e t o wri te cl e ar , c o ncis e, high-quality d oc u m e n t s .

M us t b e a bl e t o ex er cis e ju d gm e n t w i t hi n areas of ambiguity as well as e s ta blis h e d pr o ce d ure s a n d p o lici es i n order to d et er mi ne a n d t a k e ap propr i ate a c t io n.

Experience managing team expectations for project timelines, including realistic timeline estimates for HFE activities.

A deep k n o w le d g e of t h e regulatory and compliance requirements for HFE and combination product risk management .

Ability to effectively collaborate with cross-functional teams and influence key stakeholders.

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

The Device, Packaging and Process (DPP) function is a key component of Gileads Pharmaceutical Development and Manufacturing (PDM) organization, providing a portfolio of technologies for selection and implementation by product teams. These technologies enable product teams to develop and execute a strategy to differentiate our products and ensure Gilead is highly competitive in commercial markets. As the Director, Human Factors Engineering and Human-Centered Design Specialist you will support innovation and early-stage development, helping drive project strategy based on human centered design and human factors principles and methodologies as well as lead initiatives to advance human-centered design practices within the organization.

Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.

Specific Job Responsibilities

Conduct qualitative and quantitative user research to gather insights on user needs, preferences, and behaviors. Analyze research findings to identify opportunities for product and user experience improvement and innovation. Present research findings to stakeholders and provide actionable recommendations.

Develop and implement design strategies that prioritize user experience and accessibility, including creating personas, journey maps, and simulations to inform design decisions based on a deep and data-based understanding of the user experience and user needs.

Develop design concepts for devices, packaging, and instructions and create concept sketches, illustrations, and prototypes.

Use visual design principles to create instructional materials that are visually appealing and effective in conveying information and supporting safe and effective use of products.

Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through 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.

Required Education, Experience & Skills :

A Bachelors degree in biomedical engineering, industrial design, or a related scientific field with 12+ years of relevant experience, OR a M.S. degree with 10+ years of relevant experience

Strong understanding of human-centered design principles and user research methodologies.

Experience with conducting qualitative and quantitative user research.

Proficiency in design tools (e.g., Adobe Creative Suite).

Prototyping skills, including the ability to create physical and digital prototypes.

Expertise in visual design principles, including layout, typography, and color theory.

Ex p eri e nc e w i th leading HFE efforts in support of combination product development and commercialization, including a working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.

Excellent v erb al , wri tt e n, a nd in terper s o na l c o mm u nic at io n skill s are r e quir e d .

Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms .

Demonstrated ability to analyze data and identify relevant design updates.

M us t b e a bl e t o wri te cl e ar , c o ncis e, high-quality d oc u m e n t s .

M us t b e a bl e t o ex er cis e ju d gm e n t w i t hi n areas of ambiguity as well as e s ta blis h e d pr o ce d ure s a n d p o lici es i n order to d et er mi ne a n d t a k e ap propr i ate a c t io n.

Experience managing team expectations for project timelines, including realistic timeline estimates for HFE activities.

A deep k n o w le d g e of t h e regulatory and compliance requirements for HFE and combination product risk management .

Ability to effectively collaborate with cross-functional teams and influence key stakeholders.

The salary range for this position is : $210,375.00 - $272,250.00. 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 :

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 regarding recruitment and selection 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 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 ApplicantAccommodations@ for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045466

Full Time / Part Time Full-Time

Job Level Director

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