Usability & Human Factors Engineer (Medical Devices)

Location: Lincoln, Rhode Island, United States; Workplace: On-site

Salary: $90,000–$110,000 annually, plus bonus

Company

hirify.global is a Swiss-American medical device company specializing in respiratory care, non-invasive monitoring, and therapeutic solutions.

What you will do

• Plan and execute formative and summative usability studies, including protocols, participant selection, moderation, analysis, and reporting.
• Develop and maintain use specifications, task analyses, use-related risk analyses, and usability engineering files.
• Identify use-related risks with engineering, clinical, quality, and external partners, and drive design improvements based on study findings.
• Support submission dossiers for new registrations and changes to existing product approvals.
• Contribute to regulatory strategies and verification and validation requirements for new products and product changes.

Requirements

• At least 3 years of human factors or usability engineering experience in the medical device industry.
• Bachelor’s degree in biomedical engineering or a related scientific or engineering field.
• Strong technical and analytical skills, including the ability to compile scientific and engineering data and write precise technical narratives.
• Ability to understand the operating principles, design, and clinical use of complex electromechanical medical devices.
• Knowledge of IEC 62366 and FDA usability guidance.
• Ability to travel as needed, up to approximately five trips per year.

Nice to have

• In-depth knowledge of the medical device regulatory framework, including FDA requirements and EU MDR 2017/745.
• Ability to understand, translate, or speak German.

Culture & Benefits

• Opportunity to influence product quality and contribute to patient care.
• Professional and personal growth opportunities with potential for advancement.
• Medical, dental, and vision coverage.
• HSA, FSA, 401(k) matching, paid parental leave, wellness stipend, and tuition reimbursement.