Staff Engineer - Human Factors - Indianola

Role: Senior Human Factors / Usability Engineer supporting Bayer’s Radiology and Pharma device development. Responsibilities: 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. Requirements: 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. HighValue: medical devices and combination products in radiology and pharma, with focus on usability, risk management, regulatory compliance, and user advocacy. Worksetup: based in Indianola, PA, with potential for collaboration across Bayer’s global teams.