Device Development Lead, Associate Director

Role: Lead device development and program execution for Takeda's medical devices, translating product strategies into actionable plans and ensuring alignment with cross-functional teams. Responsibilities: oversee device program planning, risk management, budgeting, and compliance; manage multi-disciplinary teams through clinical development, registration, and commercialization; facilitate collaboration with global teams, external partners, and regulatory bodies; promote visibility and transparency within projects; support design transfer and lifecycle management. Requirements: BS/BEng in engineering/science with 12+ years in device development, with proven success leading global, multi-site programs in biotech or medtech; extensive experience in device commercialization, capital equipment development, and regulatory frameworks (FDA/EU MDR); strong leadership, strategic planning, risk mitigation, and stakeholder management skills. Preferred: knowledge of connected health, digital health initiatives, and quality systems. High-Value: end-to-end device development, global regulatory compliance, cross-functional leadership, lifecycle management, and working within a Stage Gate framework. Location: Lexington, MA; full-time, on-site with leadership responsibilities.