Human Factors Engineer (HFUXD) [34208]

About the Role

Diabetes Care (DC) is seeking a Human Factors Engineer to focus on Human Factors and User Experience Design (HF+UXD). HF+UXD is a scientific discipline that studies how people interact with products or systems and seeks to improve safety, efficacy, and user delight. This individual will work with minimal oversight with cross-functional teams on key programs and initiatives across DC, utilizing evidence-based tools to drive user-centered product development principles proven to reduce risks, minimize development costs, and maximize market acceptance of solutions.

The role of HF+UXD within this group is to bring knowledge and expertise in user-centered design that begins with the initiation of programs and transitions into design and development. The HF+UXD engineer will have the opportunity to engage in numerous product development programs within DC.

Responsibilities

• Serve as an individual contributor to DC project teams for Human Factors Engineering and User Experience Design, engaging in product design work and independent review.
• Usability Planning & Execution:
  • Collaborate with cross-functional teams to ensure human factors and usability plans goals are appropriately met.
  • Execute human factors and user experience design deliverables by working with minimal supervision, managing the work of external vendors, and consulting with project teams to ensure quality deliverables.
  • Manage usability and HF documentation as required.
• Generative Research & Front-End Innovation:
  • Participate as a member of the experience teams to conduct generative research including observational research (contextual inquiry and ethnography) and competitive usability assessment as required.
• Human Factors & User Experience Tools:
  • Drive understanding of the human-system interface through the creation of user profiles, environmental characterization, workflow mapping, task analysis, functional modeling, and use cases/scenarios.
  • Utilize anthropometry, biomechanics, and human capability data to support, analyze, and optimize system design and ergonomics.
• User Needs/Requirements & User Risk Assessment:
  • Distill research insights into themes that inform user needs, user risk, and user interface design.
  • Have a working understanding of the requirements management process that focuses on the creation of user needs and stakeholder requirements as part of a cross-functional team.
  • Evaluate Use Error as part of use-related risk analysis (uFMEA and/or Hazard Analysis) and contribute to mitigation efforts in partnership with medical affairs and cross-functional teams.
• Design of User Interfaces:
  • Conduct product evaluations, brainstorming sessions, competitive analysis, and other usability engineering methodologies with internal teams and external vendors.
  • Work with external teams to provide input into low to high fidelity prototyping methods to enable quick turn customer-centric design loops that power Agile processes and decision making.
• Formative Evaluation, Design Validation, and Summative Human Factor Design Validation:
  • Design, plan, execute, analyze, and report using qualitative and quantitative research as part of formative study evaluation which may include heuristic evaluation, expert review, simulated use studies, and actual use studies.
  • Serve as support, executional lead, and/or contact for external vendors and business group Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation.
  • Partner with internal and external teams such as Global Clinical Development, Pre-Clinical Development, and Medical Affairs to perform Pre-Clinical and Clinical Studies.

Requirements

• 2+ years of technical experience.
• Bachelor’s Degree in a technical field (human factors related degree preferred).
• Working knowledge of applicable standards and industry guidance for medical devices and usability engineering including: IEC 62366-1, FDA Guidance for Human Factors (2016), ISO 13485, FDA Guidance for Design Controls, ISO 14971.
• Capable of performing usability studies and translating HF+UXD findings into user-needs/requirements, user risk, and/or design solutions related to the user interface.
• Previous experience in a user experience and/or human factors role.

Preferred Qualifications

• 2+ years of experience working with medical devices.
• Experience leading and/or supporting work streams that include outside partners and/or internal team members.
• Highly motivated self-starter able to achieve results with minimal oversight.
• Excellent written and verbal communication skills, with ability to present complex ideas to multiple levels.
• Strong creative, analytical, and problem-solving skills.
• Strong technical judgement, leadership, and interpersonal skills.
• Strong facilitation and analytic skills with an open mind.
• Proficient knowledge of engineering first principles.
• Working understanding of the End to End Product Development Process.

Schedule

12+ months contract, 40 hours per week.