Principal Product Usability Engineer

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Research & Development 

 

Summary:

 

The Principal Product Usability Engineer will work with and independently lead global cross-functional project teams to drive user-centered design by applying human factors and usability expertise, process, and principles for new product commercialization, as well as sustaining, design to value, and cost savings programs, across Hollister’s Ostomy and Continence Care Portfolios.

 

This role will provide, through in-depth industry knowledge and expertise, consultation to project teams on appropriate Usability strategy for the product(s) in scope of each project from the human factors/usability engineering, user needs, and user experience perspectives, planning and executing appropriate activities, and required deliverables and ensuring that the activities and deliverables meet the requirement from both the internal quality and the regulatory perspectives. Considered an internal subject matter expert who identifies opportunities to advance the Usability capability within Hollister, as well as areas in which the Usability capability within Hollister needs to evolve with evolving markets, users, technologies, and regulation.

 

Hollister operates in a hybrid work environment.

 

Responsibilities:

 

• Provide Human Factors and Usability Engineering expertise across the Ostomy and Continence Care product ranges including identifying, planning, monitoring, and executing product development activities for projects to ensure best-in-class user experiences and satisfy regulatory requirements.
• Drive user-centered design and the use of Human Factors and Usability Engineering process.
• Collaborate with new product commercialization teams to develop usability and user need requirements, leveraging appropriate research methodologies, analyses, and deliverables.
• Use appropriate Human Factors and Usability Engineering techniques to understand end user behavior, preferences, and use cases and integrate them into design requirements and concepts.
• Design and direct concept evaluations and formative usability studies during new product development and summative usability studies for human factors validation.
• Develop study protocols, set up appropriate study environments, manage participant recruitment and study site(s), moderate usability sessions, analyze test results, identify design improvement opportunities and recommendations, and develop study reports.
• Develop Summary Human Factors/Usability Engineering Reports that adhere to industry standards.
• Conduct Use-Related Risk Analyses to identify use errors and design mitigations, as well as opportunities to improve user experience(s).
• Lead the Human Factors/Usability Engineering Community of Practice and identifies opportunities to advance the Usability capability.
• Evaluate change controls to understand whether the proposed change will change the way in which the product meets user needs, use-related risk of the product, and/or interaction-level usability, as well as the appropriate actions in response.

Requirements:

• Number of Overall Years Necessary: 12-15
  • Note the number of years’ experience could be less if hold a Master’s or PhD
• BS, MS, or PhD in Engineering (Human Factors, Biomedical, Industrial), Psychology (Cognitive or Experimental), or equivalent and at least 5 years of experience performing Human Factors and Usability Engineering in medical device design and development, with demonstrated ability to tailor industry standards and guidance appropriately.
• Understand Human Factors and Usability, ergonomics, and data collection and analysis principles in the user-centered design of medical devices.
• Experience applying Human Factors and Usability Engineering process in medical device development.
• Experience complying with international usability standards (i.e., IEC 62366, ISO 14971, ANSI/AAMI HE75) and FDA and other applicable regulations.
• Demonstrated ability to draw conclusions and make recommendations based on technical input from cross-functional team members.
• In-depth understanding of 21 CFR Design Controls.
• Demonstrated ability to work