Engineering Director
Core
Lead the Surgical Operating Unit's New Product Development Risk Management and Reliability Quality team to ensure patient safety and product quality throughout the medical device lifecycle.
Role type
Senior IC Engineering Director (Quality Engineering)
Builds
Safe, effective, and compliant medical devices for the Surgical Operating Unit
Domain
Medical device industry, Quality Engineering, Risk Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, strategic planning, performance management, regulatory compliance, risk management, budget management, cross-functional collaboration
Preferred skills
Reliability science, design controls, statistical methods and analysis, quality management systems
Technologies
ISO 14971, ISO 13485, IEC 62304, FDA Part 820
Responsibilities
Lead and develop the Risk Management and Reliability Quality team, establish performance goals and targets, direct employees in design and development of medical devices, develop and improve policies and processes, select and develop talent, collaborate across functions, manage departmental budget, lead risk management file creation and reviews, ensure compliance with regulatory requirements
Seniority
Director, strategic leadership & team management
