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 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 skills in early-stage development drive the need for additional Human Factors expertise, including a specialist to identify, improve, and maintain processes that support the work of the HFCOE.

We are looking for an individual with training in human factors/usability engineering for a Human Factors role to support our Combination Product development efforts with a focus on Process Excellence.

Overview of Position:

This role is intended to support the DCPD HFCOE in optimizing the processes that the team follows in its day-to-day development work. This individual will work alongside existing AbbVie HFCOE team members and key stakeholders to establish optimal processes that make best practices accessible and actionable for the team. In addition to serving as process owner for key HFCOE processes, and with the objective of developing and keeping up to date on skills as an HF practitioner, this individual will also spend some time supporting product development of device and combination products, working with Engineering, Medical, Compliance and Regulatory staff to design user interfaces and HF studies required to ensure ease-of-use, safety, user acceptance, and regulatory approval. The individual will perform the following functions to support Process Excellence within the HFCOE: · Use established methods to diagnose the current state of a process and identify pain points and improvement opportunities · Use established process improvement tools to identify and implement countermeasures that improve process efficiency, quality, and/or compliance · Establishes process strategy, objectives and long-range roadmap with input from key stakeholders (HFCOE team members, Scientific Compliance, other DCPD process owners, and Quality Assurance, as needed); identifies, facilitates/implements process changes · Create and maintain relevant documentation related to the processes, such as best practice guidelines, job aids, and/or SOPs · Serve as resident expert within HFCOE for any information management tools that may support processes (e.g., sharepoint, smartsheet)

Other Functions: · Perform the following functions as HF Lead in support of product development:

o Design and conduct user research

o Perform task and workflow analyses o Work with System Engineers to develop user needs and user interface specifications

o Conduct and evaluate Use-related Risk Analyses, recommend and evaluate design mitigations o Design device and system user interfaces and associated instructional materials

o Design and conduct usability tests and other usability assessments o Design, conduct and analyze interviews and surveys

o Prepare and compile thorough documentation for inclusion in regulatory submissions