Human Factors Engineer (HF+UXD) [34208]

Responsibilities

• 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
• Participate as a member of the experience teams to conduct generative research including but not limited to observational research (contextual inquiry and ethnography), competitive usability assessment as required
• 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
• Distill research insights into themes that inform user needs, user risk, and user interface design
• Have 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
• 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
• Design, plan, execute, analyze, and report using qualitative and quantitative research as part of formative study evaluation which may include but are not limited to 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

• 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.