Principal Human Factors Engineer (Medtech)

Location: Plymouth, MN, US; hybrid work arrangement with travel up to 25%, primarily within the United States, plus occasional international travel.

Salary: $150,000–$185,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive sonic beam therapy based on histotripsy, with current and planned applications across multiple medical specialties.

What you will do

• Lead human factors strategy and execution across projects from early design definition and feasibility through launch and post-market monitoring.
• Partner with cross-functional teams and clinical partners to understand users, use environments, clinical workflows, and products.
• Develop use-related risk assessments, support user interface design, and identify usability improvements.
• Plan, execute, document, and synthesize formative and summative usability studies in line with regulatory expectations and internal procedures.
• Prepare controlled Human Factors documentation and regulatory submission packages, and develop responses to regulatory agency questions.
• Lead post-market Human Factors activities, improve processes and methods, shape Human Factors and UX/UI strategy, and mentor human factors engineers.

Requirements

• 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 experience developing and commercializing medical devices.
• Extensive experience leading human-factors engineering activities for multiple complex workstreams with limited supervision.
• Expert-level competency in human factors lifecycle activities, 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 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 and working in matrixed organizations and cross-site/global teams.
• Ability to travel up to 25%, primarily within the United States, to hirify.global offices, customer locations, clinical study sites, and usability testing facilities; occasional international travel may be required.

Culture & Benefits

• Collaborative work culture combining advanced science with real-world medical applications.
• Health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k) and paid time off.
• Full-time employee benefits package and commitment to an inclusive, equal-opportunity workplace.
• Visa sponsorship is not available; U.S. work authorization is addressed by the employer.