Principal Engineer - Human Factors - Indianola, PA

Lead Human Factors / Usability Engineering for Bayer’s Radiology and Pharma device portfolios, ensuring user-centric design and regulatory compliance.

• develop and execute HF/UE strategies
• manage usability evaluations across product lifecycle
• lead use-related risk analyses
• contribute to device design and verification activities
• document HF/UE outcomes for submissions
• advocate for user-centric practices

• Master’s in engineering, ergonomics, psychology, or related field with 7+ years (or Bachelor's with 10+ years) of HF/UE experience
• expertise in IEC 62366-1, FDA HF/UE guidance, risk management (ISO 14971), design controls (CFR 820.30, ISO 13485), and global regulatory standards including EU MDR
• proven experience with regulated medical devices or combination products, and successful regulatory interactions, especially with US FDA

• Strong leadership and communication skills, experience in device development, and a patient/user advocacy mindset

• Medical devices and drug-device combination products, regulated environment, global regulatory compliance, emphasis on user safety and usability validation

based in Indianola, PA, with collaboration across cross-functional teams.