Background:
The AbbVie Device & Combination Product Development (DCPD) function provides design and development expertise to enable drug delivery systems for AbbVie biopharmaceuticals. The Human Factors Center of Excellence (HFCOE) within DCPD manages the drug delivery device and stand-alone medical device user interface design process and executes usability assessments required to support the successful regulatory submission of AbbVie products. A combination of an increase in the number of drugs that require a delivery device, stand-alone medical devices, and increasing engagement of Human-Centered Design and HF methods in early-stage development drive the need for additional Human Factors expertise.
We are looking for an individual with academic training and professional experience in human factors/usability engineering or a related discipline for a Human Factors role to support our product development efforts.
Overview of Position:
This role is intended to support the DCPD HFCOE’s need to manage projects to design, test and validate combination products and medical devices. This individual will work alongside existing AbbVie HF, Engineering, Medical, Compliance and Regulatory staff to design device user interfaces and HF studies required to ensure ease-of-use, safety, customer acceptance, and regulatory approval.
Major Responsibilities:
The individual will perform the following functions in partnership with internal colleagues and/or third-party HF firms:
- Determine and lead the human factors engineering strategy for product development projects
- Design and conduct contextual inquiry research
- Perform task and workflow analyses
- Work with System Engineers to develop user needs requirements and user interface specifications
- Conduct and evaluate Use-Related Risk Analyses, and recommend and evaluate design mitigations to use-related risks
- 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
- Develops and achieves human factors engineering strategy in alignment with functional goals and project objectives.
- Presents human factors engineering concepts and results for functional scientific and non-scientific leaders as well as potential and existing partners. Maximizes impact and value of expertise.
- Applies innovation by creating and implementing alternative or improved approaches for conducting human factors engineering at AbbVie.
- Advances expertise within function. Proactively advises and shares knowledge and expert opinions with peers and senior management. Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
- Collaborates with experts within function to integrate objectives into activities associated with development of new/improved products or technology.