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Lead Human Factors Specialist

2 months ago

Eden Prairie, Minnesota, United States Acist Medical Systems Full time

The Principal Human Factors Engineer role at Acist Medical Systems is a pivotal technical leadership position responsible for defining, designing, and assessing the usability of medical products. In this capacity, you will spearhead human factors and usability engineering initiatives throughout the product development process, collaborating closely with interdisciplinary teams to create and validate user-centered solutions.

Key Responsibilities:

  • Gain a comprehensive understanding of the clinical landscape and technical aspects of Acist Medical Systems' products to provide expert Human Factors support.
  • Oversee the planning, execution, and documentation of human factors engineering activities throughout the product lifecycle.
  • Utilize human factors methodologies to influence the design, development, and assessment of medical devices, including:
    • Conducting ethnographic research to identify user demographics and their specific needs.
    • Translating user requirements into design specifications and product concepts.
    • Creating user interface prototypes through iterative usability testing to validate design concepts.
    • Performing analyses of workflows, tasks, and potential user errors.
    • Ensuring the integration of human factors principles into product design.
  • Identify user demographics, environments, use cases, and critical tasks for comprehensive task analysis, instructional materials, user training, and system validation.
  • Collaborate with cross-functional teams to develop User Needs Requirements that inform design decisions in relevant clinical settings.
  • Manage the Usability Engineering plan for each product, establishing standardized workflows as a hallmark of Acist Medical Systems' offerings.
  • Develop protocols, conduct system evaluations, and prepare reports, including usability engineering plans, task analyses, use error analyses, requirements documentation, usability protocols, and validation testing in partnership with clinical and marketing teams.
  • Address technical challenges by providing guidance to product and engineering teams through thorough trade-off analyses to develop effective solutions.
  • Analyze and compile reports from summative and formative testing, along with Human Factors/Engineering Summary reports.
  • Collaborate with technical leaders to cultivate significant and impactful Intellectual Property related to clinical workflows, supporting business growth.
  • Ensure compliance with the Acist Medical Systems Quality Management System (QMS), including the development and maintenance of necessary documentation.
  • Design products that adhere to regulatory requirements set forth by governing bodies.
  • Mentor and guide junior human factors engineers.
  • Commit to fostering a culture of continuous improvement within the team.