Human Factors Engineer

1 month ago

Andover, Massachusetts, United States MILLENNIUMSOFT Full time
Job Title: Human Factors Engineer

We are seeking a skilled Human Factors Engineer to join our team at MillenniumSoft. As a Human Factors Engineer, you will play a critical role in designing and developing user-centered products that meet the needs of our customers.

Responsibilities:
  • Collaborate with cross-functional teams to ensure human factors and usability plans are effectively implemented.
  • Develop and execute human factors and user experience design deliverables, working with minimal supervision and managing external vendors as needed.
  • Manage usability and HF documentation, ensuring quality deliverables and compliance with industry standards.
  • Participate in generative research, including observational research, competitive usability assessment, and human factors and user experience tools.
  • Drive understanding of the human-system interface through 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.
  • 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 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.
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, FDA Guidance for Human Factors (2016), ISO 13485, FDA Guidance for Design Controls, and 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 judgment, 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.

Language: English

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