Senior Lead, Human Factors & Usability Engineering

Cintrifuse; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Cintrifuse in Cincinnati, OH, is seeking a senior Human Factors Engineer to lead usability engineering activities in compliance with FDA, IEC, and ISO standards. You will develop and maintain HFE/Usability Files and supervise formative and summative studies to support regulatory submissions.

You will translate user needs into design inputs, collaborate with engineering, quality, and regulatory teams, and manage IFUs, risk assessments, and post-market activities.

Qualifications

• Bachelor's degree in engineering, design, psychology, or human factors.
• 8+ years in a regulated industry, preferably in medical devices/pharma.
• Experience leading cross-functional, matrixed teams and usability studies.
• Familiarity with ISO, FDA, MDD regulations and IEC 62366-1.
• Experience interfacing with external customers and contractors.
• Proficient in MS Office (Word, Excel, PowerPoint, Project).

Responsibilities

• Lead human factors and usability engineering activities per FDA/IEC/ISO standards.
• Conduct formative and summative usability studies with or via agencies.
• Translate user needs into design inputs; influence device design and labeling.
• Create and maintain IFUs; ensure content reflects validated workflows and risks.
• Lead risk analysis and mitigations; ensure traceability to design solutions.
• Provide HF input during design reviews and post-market activities.
• Harmonize HF documentation for regulatory submissions and communications.

Skills

Cross-functional leadership

User-centered design

Qualitative & quantitative data

FDA/IEC regulatory understanding

Project management

Communication

Problem solving

Team leadership

Microsoft Office

Education

Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors

MBA or MS in Engineering, Industrial Design, Psychology, or Human Factors

Tools

Microsoft Office

Job description

Cintrifuse in Cincinnati, OH, is seeking a senior Human Factors Engineer to lead usability engineering activities in compliance with FDA, IEC, and ISO standards. You will develop and maintain HFE/Usability Files and supervise formative and summative studies to support regulatory submissions.

You will translate user needs into design inputs, collaborate with engineering, quality, and regulatory teams, and manage IFUs, risk assessments, and post-market activities.