Director Engineering, New Product Development
Core
Lead manufacturing engineering teams to develop, qualify, and transfer processes for new cardiovascular surgical devices from R&D to commercial production.
Role type
Director, Manufacturing Engineering (New Product Development)
Builds
New cardiac surgery devices and manufacturing processes for global commercialization
Domain
Medical Devices / Cardiovascular Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process development, Design for manufacturability, Six Sigma, LEAN, cGMP, Supplier development, Process validation, Project management, Financial acumen, Organizational change management, Cross-functional leadership
Preferred skills
Advanced engineering degree, Six Sigma Black Belt certification, Class II & III medical device design controls knowledge (implantable NiTi, CoCr, tissue, mechanical devices, catheter-based systems)
Technologies
Six Sigma, LEAN, cGMP
Responsibilities
Manage manufacturing engineers for new product development and transfer; Partner with R&D and supply chain for global product launch; Lead process development and design for manufacturability; Develop talent and project plans; Drive capacity expansion and cost reduction initiatives.
Seniority
Director, people leadership