The AbbVie Combination Product Development (CPD) function provides design and development expertise to enable drug delivery systems for AbbVie biopharmaceuticals. The Human Factors (HF) group within CPD manages the drug delivery device user interface design process and executes usability assessments required to support the successful submission of AbbVie Combination Products. An increase in the number of AbbVie products requiring a delivery device along with increased commitment to Human-Centered Design in early stage clinical development has created the need for additional senior-level Human Factors expertise.
We are looking for an individual with academic training and extensive professional experience in human factors/usability engineering. This will be a senior-level Human Factors role reporting directly to the Director, Human Factors.
Apply at https://careers.abbvie.com/abbvie/jobs/2007894?lang=en-us&previousLocale=en-US.
Overview of Position:
This role will support CPD projects through the design, testing and validation of drug delivery devices. This individual will work alongside existing AbbVie HF, Engineering, Medical, Compliance and Regulatory staff to design device user interfaces and conduct HF studies required to ensure ease-of-use, safety, customer acceptance, and regulatory approval.
The individual will perform the following functions in partnership with third-party HF firms:
Design and conduct contextual inquiry research
Perform task and workflow analyses
Work with System Engineers to develop user requirements and user interface specifications
Conduct and evaluate Use Related Risk Assessments, recommend and evaluate design mitigations
Design device and system user interfaces and associated instructional materials
Design and conduct usability tests and other usability assessments
Design, conduct and analyze interviews and surveys
Prepare and compile thorough documentation for inclusion in regulatory submissions
Educate and evangelize HF best practices throughout the organization
Maintain corporate policy, procedures and tools on best practices for HF
Assist in training internal staff to perform some HF functions under supervision
Facilitate the selection and proper use of outside HF consultants
BA/BS, MA/MS, or PhD in Human FActors, Industrial Engineering, Human Computer Interaction, Psychology or related discipline
Minimum of 18+ (BA/BS), 16+ (MA/MS) or 10+ (PhD) years of experience in pharmaceutical or medical device product development is required
Working knowledge with medical devices and medical device regulations and standards (FDA HF guidance; ANSI/AAMI HE75; IEC 62366-1:2015) is required
Strong working knowledge of Human Factors methods and principles.
Experience in user interface design and usability testing
Excellent written and spoken communications skills
Ability to work with a variety of disciplines and teams in fast-paced environments
Strong problem-solving and analytical skills
*Job level will be commensurate with experience
Job locations include North Chicago, IL, Irvine, CA, and Santa Cruz, CA.
Internal Number: 2007894
About AbbVie, Inc.
How will your passion influence our future?
AbbVie’s Combination Product Development function enables best-in-class drug delivery systems for AbbVie biopharmaceuticals. Are you an innovative and collaborative engineer with experience in Human Factors? We’re seeking a Senior Principal level Engineer to join our team!