Senior Principal Engineer, Human Factors

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.

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 submission

Other Functions:

• 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