Staff Engineer - Human Factors - Indianola

Senior Human Factors / Usability Engineer supporting Bayer’s Radiology and Pharma device development.

• develop and execute HF/UE strategies ensuring compliance with industry standards and regulations (IEC 62366-1, FDA guidance)
• plan and lead usability evaluations across product lifecycle
• conduct use-related risk analyses (URRA, UFMEA)
• contribute to device requirements, UI design, and V&V activities
• document HF/UE findings for design documentation and submissions
• support regulatory interactions and stakeholder engagement
• promote a user-centric approach within the organization.

• Master’s in engineering, ergonomics, psychology, or related field with 4+ years (MS) or 7+ years (BS) HF/UE experience
• expertise in regulated medical device development, risk analysis, and regulatory submissions, particularly with US FDA
• strong understanding of IEC 62366-1, ISO 13485, ISO 14971, and EU MDR
• excellent communication skills in English
• ability to work in a global matrix environment.

medical devices and combination products in radiology and pharma, with focus on usability, risk management, regulatory compliance, and user advocacy.

based in Indianola, PA, with potential for collaboration across Bayer’s global teams.