Principal Human Factors Engineer - MedTech UX Leader

HISTOSONICS INC; Plymouth (MN); On-site; USD 150,000 - 185,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Life, short-term and long-term disabil

401(k)

Paid time off

Job summary

HistoSonics is seeking a Principal Human Factors Engineer in Plymouth, MN. This role leads HF strategy and execution with autonomy, guiding pre- and post-market activities and influencing UI/UX design across a portfolio of projects.

You will mentor HFEs, partner with clinical and cross-functional teams, and ensure compliance with ISO 14971, IEC 62366, and FDA HF guidance while driving continuous usability improvements.

Qualifications

• 10+ years of progressive product development experience in medical devices.
• Expert-level HF activities across multiple complex workstreams with limited supervision.
• Deep knowledge of HF standards including ISO 14971, IEC 62366, IEC 60601, ANSI/AAMI HE75, FDA HF guidance.

Responsibilities

• Lead HF strategy and execution across projects from design to post-market.
• Mentor HFEs and partner with cross-functional leaders to advance UX/UI strategies.
• Plan and document formative and summative usability studies per regulatory expectations.
• Author HF documentation for all product development phases and regulatory submissions.
• Drive post-market HF activities and translate field insights into improvements.

Skills

Leadership in HF

Medical devices

Usability testing

Regulatory knowledge

Cross-functional collaboration

Customer interfacing

FDA/HF guidance familiarity

Travel readiness

Education

Bachelor’s degree in HF/BME/IE/Psychology/Product Design or related field

Job description

HistoSonics is seeking a Principal Human Factors Engineer in Plymouth, MN. This role leads HF strategy and execution with autonomy, guiding pre- and post-market activities and influencing UI/UX design across a portfolio of projects.

You will mentor HFEs, partner with clinical and cross-functional teams, and ensure compliance with ISO 14971, IEC 62366, and FDA HF guidance while driving continuous usability improvements.