Principal Human Factors Engineer - MedTech Usability Leader

HistoSonics, Inc.; Plymouth (MN); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Life, disability insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. in Plymouth, MN seeks a Principal Human Factors Engineer to lead HF strategy, oversee pre- and post-market activities, and mentor junior engineers within a regulatory-driven medical device program.

You will collaborate with UX/UI and cross-functional teams, drive usability studies, prepare documentation for regulatory submissions, and help shape HF and UX strategies while ensuring high-quality, patient-centered design.

Qualifications

• Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, Product Design, or related technical discipline.
• 10+ years of progressive product development experience in medical devices.
• Expert-level competency in human factors activities across product lifecycle and regulatory submissions.

Responsibilities

• Lead HF strategy and execution across multiple projects from design through post-market.
• Partner with cross-functional teams to understand users, workflows and environments.
• Plan, conduct, and document formative and summative usability studies.
• Prepare and assemble HF documentation for regulatory submissions and inquiries.
• Mentor and develop junior HF engineers and promote best practices.

Skills

Hands-on leadership

Regulatory collaboration

User-centered design

Cross-functional teamwork

Education

Bachelor’s degree in Human Factors Engineering or related field

Tools

ISO 14971 knowledge

IEC 62366 knowledge

FDA HF guidance familiarity

Job description

HistoSonics, Inc. in Plymouth, MN seeks a Principal Human Factors Engineer to lead HF strategy, oversee pre- and post-market activities, and mentor junior engineers within a regulatory-driven medical device program.

You will collaborate with UX/UI and cross-functional teams, drive usability studies, prepare documentation for regulatory submissions, and help shape HF and UX strategies while ensuring high-quality, patient-centered design.