Principal Human Factors Engineer

HistoSonics, Inc.; Minneapolis (MN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. in Plymouth, MN seeks a Principal Human Factors Engineer to lead human factors strategy across pre- and post-market activities for the Edison System.

You will mentor HFEs, partner with UX/UI and cross-functional teams, and drive usability improvements in both physical and digital interfaces. The role requires a strong background in medical devices, ISO 14971 / IEC 62366 compliance, and up to 25% travel to US sites and customer locations to support usability testing and

Qualifications

• Bachelors degree in a related technical discipline.
• 10+ years of product development experience in medical devices.
• Experience leading HF activities across multiple complex workstreams.
• Expert knowledge of ISO 14971, IEC 62366, IEC 60601, ANSI/AAMI HE75, and FDA HF guidance documents.
• Ability to travel up to 25% in the United States.

Responsibilities

• Lead human factors strategy across projects from design to post-market.
• Partner with cross-functional teams and clinical partners to understand users and workflows.
• Develop analyses and use-related risk assessments for design, labeling, and systems.
• Plan, execute, and document formative and summative usability studies.
• Prepare regulatory submissions and respond to agency questions.
• Mentor HFEs and drive process improvements.

Skills

Leadership

User-centered design

Regulatory affairs

Cross-functional collaboration

Travel readiness

Education

Bachelor9s degree in related technical discipline

Job description

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location

Plymouth, MN

Position Summary (Why This Role Matters)

The Principal Human Factors Engineer (HFE) is an expert-level technical leader responsible for human factors strategy and execution. Working with a high degree of autonomy, they lead critical pre- and post-market workstreams and influence physical and digital user interface design. They strengthen Human Factors processes, mentor HFEs, and partner with cross-functional leaders to advance an inclusive, highly collaborative culture.

Key Responsibilities (What You’ll Do)

• Lead human factors strategy and execution across a portfolio of projects and domains, from early design definition and feasibility through launch and post-market monitoring.
• Typical activities on an assigned workstream include:
  • Partner with cross-functional teams and clinical partners to build a deep understanding of users, use environments, clinical workflows, and our product.
  • Develop targeted analyses and use-related risk assessments that inform the design of systems, accessories, and labeling.
  • Support concept generation and iterative design of our user interfaces with cross-functional partners.
  • Plan, execute, and document formative and summative usability studies in accordance with applicable regulatory expectations and internal procedures.
  • Synthesize insights and identify solutions and usability improvements.
  • Present findings to cross-functional teams and leadership.
  • Author controlled Human Factors documentation for all phases of the product development process.
  • Compile high-quality Human Factors document packages for HistoSonics regulatory submissions and develop responses to questions from regulatory agencies.
• Lead post-market Human Factors activities, translate field and surveillance insights into actionable recommendations, and drive continuous usability improvements.
• Partner with UX/UI designers and cross-functional teams to apply targeted Human Factors methods that strengthen the digital experience and overall system usability.
• Lead continuous improvement of Human Factors processes, methods, templates, and best practices to increase consistency, efficiency, and regulatory readiness.
• Partner with the Director and senior leaders to shape Human Factors and UX/UI Design strategy, including capability development, operating priorities, and long-range planning.
• Mentor human factors engineers to support their professional development.

Qualifications And Skills

• 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.

Benefits

We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short‑term and long‑term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

U.S. Work Authorization & Sponsorship

Employer will not sponsor visas for position.