Principal Human Factors Engineer - MedTech UX Leader

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, 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