Director Human Factors & Sustaining Engineering

Responsibilities

• Recruit, mentor, and develop human factors and sustaining engineering teams across development and commercial stages
• Lead usability study strategy, execution, and regulatory submissions for combination products in development
• Oversee design control processes including verification, validation, design transfer, and change management
• Conduct design change assessments and manage customer complaint investigations with root cause and CAPA documentation
• Author and review technical documentation including protocols, risk management files, and regulatory responses for agency submissions

Requirements

• BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field
• 10+ years experience (Associate Director level) or 12+ years (Director level) in relevant field
• Proven people leadership experience with technical, cross-functional teams
• Medical device, biopharmaceutical combination product, or regulated industry background
• Prior experience with sustaining engineering, design controls, or product lifecycle management
• Knowledge of IEC 62366, AAMI HE75, ISO 14971, FDA guidance, and 21 CFR design control regulations