Principal Human Factors Engineer
$150,000–$185,000 year
HybridPlymouth, Minnesota, United States
Job Summary
Lead human factors strategy and execution across a portfolio of projects from early design through post-market monitoring. Partner with cross-functional teams and clinical partners to build deep understanding of users, environments, and workflows. Develop targeted analyses and risk assessments that inform system design, labeling, and digital user interfaces. Plan and execute formative and summative usability studies while synthesizing insights to drive iterative design improvements. Author controlled Human Factors documentation for regulatory submissions and compile high-quality document packages for FDA responses. Lead continuous improvement of Human Factors processes, methods, and best practices to enhance regulatory readiness. Mentor human factors engineers and shape long-range strategy with senior leaders. Present findings to cross-functional teams and leadership to advance an inclusive, collaborative culture. Travel up to 25% within the U.S. to support offices, clinical sites, and testing facilities.
Required Qualifications
- Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, Product Design, or a related technical discipline
- 10+ years of progressive product development experience, including significant hands-on expertise in the development and commercialization of medical devices
- Extensive track record of successfully leading human-factors engineering activities for multiple complex workstreams with limited supervision
- Expert-level competency in tools and processes used for human factors activities throughout the product lifecycle, including activity scoping, ethnographic research, stakeholder needs identification, workflow design, task analysis, requirements development, user interface design and documentation, use error analysis, and formative and summative usability testing
- Deep understanding and applied knowledge of Human Factors and Risk Management standards and guidance, including ISO 14971, IEC 62366, IEC 60601, ANSI/AAMI HE75, and FDA Human Factors guidance documents
- Experience interfacing with customers
- Experience working in matrixed organizations and cross-site/global teams
- Ability to travel up to 25%, primarily within the United States, to support activities at HistoSonics offices, customer locations, clinical study sites, and usability testing facilities. Occasional international travel may be required.
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