Lead Human Factors Specialist

2 weeks 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 medical products. This role entails spearheading human factors and usability engineering initiatives throughout the product development process, collaborating closely with cross-functional 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' devices to provide expert Human Factors support in medical device development.
  • Oversee the planning, execution, and documentation of human factors engineering activities throughout the product lifecycle.
  • Utilize human factors principles and methodologies to shape the design, development, and evaluation of medical devices, including:
    • Conducting ethnographic user research to identify user demographics and their requirements.
    • Translating user needs 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 the design process.
  • Identify user groups, environments, use scenarios, and critical tasks for task analysis, instructional materials, user training, and system verification and validation.
  • Collaborate with cross-functional teams to develop User Needs Requirements that inform design decisions within relevant clinical settings.
  • Own the usability engineering strategy for each product and standardize workflows as a proprietary branding for Acist devices.
  • Develop protocols, conduct system evaluations, and produce reports, including usability engineering plans, task analyses, use error analyses, requirements development, usability protocols, and validation tests in partnership with clinical and marketing teams.
  • Address technical challenges by providing guidance to product and engineering teams through comprehensive trade-off analyses to devise robust and effective solutions.
  • Analyze and prepare reports from summative/formative testing and Human Factors/Engineering Summary reports.
  • Collaborate with functional technical leaders to develop significant and impactful intellectual property related to clinical workflows to support business growth.
  • Ensure compliance with the Acist Medical Systems Quality Management System (QMS), including the development and maintenance of necessary documentation.
  • Design products that meet the requirements set forth by regulatory bodies such as the FDA, UL, CE, and others as specified by product management.
  • Mentor and provide support to junior human factors engineers.
  • Commit to fostering a culture of continuous improvement in work output and environment.

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