Principal Human Factors Engineer

Roche•South San Francisco, CA

45d

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche! The Opportunity The Principal Human Factors Engineer will be responsible for providing human factors engineering expertise to project teams developing combination product drug delivery devices for parenteral pharmaceutical therapeutics at Genentech, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered. The Principal Human Factors Engineer has strong experience in human factors engineering for combination products and/or medical devices. They will collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative products and ensure that those products are safe and easy to use. The candidate has demonstrated ability to lead project-level human factors activities, including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and design validation studies. They will also develop instructions for use and training materials for clinical trial and commercial purposes. The Principal Human Factors Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members. The work is reviewed with a focus on long-term perspectives, as the Principal Human Factors Engineer establishes his/her own work priorities and timelines.

Requirements

B.S, M.S, or advanced degree in human factors engineering, cognitive psychology, industrial engineering, bioengineering, or related discipline.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor’s degree.
In depth experience in writing technical documents, analyzing data, writing usability study protocols, performing statistical data analysis and writing summary reports is expected.
Strong skills in relevant modeling and design tools, design controls and/or data analysis. For example: Ability to generate and analyze large data sets, including quantitative and qualitative analysis
Advanced knowledge of design controls and relevant human factors standards and guidances
Development of product training and instructions for use, design and execution of formative and summative usability studies, use-related risk analysis, and other human factors methods
A proven track record of working effectively in a matrixed organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
Excellent communication skills are required.
Highly organized and detail oriented.
Excellent leadership skills.

Nice To Haves

Experience in working with external partners is also highly desirable.

Responsibilities

providing human factors engineering expertise to project teams developing combination product drug delivery devices for parenteral pharmaceutical therapeutics at Genentech, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered
collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative products and ensure that those products are safe and easy to use
lead project-level human factors activities, including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and design validation studies
develop instructions for use and training materials for clinical trial and commercial purposes
initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems
provide guidance and coordinate work activities of other personnel and may also supervise staff members
establish his/her own work priorities and timelines