Director Human Factors & Sustaining Engineering

Role: Director of Human Factors at Regeneron to lead usability strategy, study execution, and regulatory engagement for combination products in development and post-market. Responsibilities: manage and mentor human factors and sustaining engineering teams supporting multiple lifecycle stages; ensure compliance with regulations (IEC 62366, FDA guidance, ISO standards), oversee design control, change management, and post-market surveillance; collaborate with cross-functional teams including design, engineering, clinical, quality, and regulatory; lead documentation and regulatory submissions, and conduct root cause analyses for customer complaints. Qualifications: BS/BA in Engineering, Human Factors, Biomedical Engineering, or related; 10+ years (Associate Director level) or 12+ years (Director level) of experience in regulated medical device or biopharma environments with prior leadership; expertise in combination products, design control, and lifecycle management; hands-on experience managing design changes, risk management, and regulatory documentation. High-Value: medical device/biopharmaceutical combination products, human factors engineering, lifecycle management, regulatory compliance, design controls, post-market surveillance, and cross-functional stakeholder collaboration. Work Setup: based in East Greenbush, NY; hybrid work model; 15% travel domestically and internationally.