Lead Human Factors Architect – MedTech UX & Safety

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

Benefits offered by this job

Health, dental, vision insurance

Life and disability insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. is seeking a Principal Human Factors Engineer in Plymouth, MN to lead human factors strategy for the Edison System.

You will oversee pre- and post-market workstreams, mentor HFEs, and collaborate with cross-functional leaders to advance an inclusive culture focused on usability and regulatory readiness. The role requires expert-level HF skills, extensive medical device experience, and travel up to 25% within the United States.

Qualifications

• Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, Product Design, or related field.
• 10+ years of progressive product development experience in medical devices.
• Proven leadership of human-factors activities across multiple complex workstreams.
• Expert-level proficiency in HF methods, scoping, ethnographic research, task analysis, and usability testing.
• Strong knowledge of ISO 14971, IEC 62366, IEC 60601, ANSI/AAMI HE75, and FDA HF guidance.
• Experience interfacing with customers and working in matrixed/global teams.
• Willingness to travel up to 25% within the US; occasional international travel.

Responsibilities

• Lead HF strategy and execution across projects from design to post-market monitoring.
• Partner with cross-functional teams and clinical partners to understand users and workflows.
• Develop use-related risk assessments to inform design of systems and labeling.
• Support concept generation and iterative UI design with cross-functional partners.
• Plan and conduct formative and summative usability studies per regulatory expectations.
• Synthesize insights and present findings to teams and leadership.
• Author HF documentation for all product development phases and regulatory submissions.
• Translate field insights into actionable usability improvements.

Skills

HF engineering

Medical device development

Regulatory knowledge

Usability testing

Cross-functional collaboration

Education

Bachelor’s degree in Human Factors/related field

Job description

HistoSonics, Inc. is seeking a Principal Human Factors Engineer in Plymouth, MN to lead human factors strategy for the Edison System.

You will oversee pre- and post-market workstreams, mentor HFEs, and collaborate with cross-functional leaders to advance an inclusive culture focused on usability and regulatory readiness. The role requires expert-level HF skills, extensive medical device experience, and travel up to 25% within the United States.