Senior Engineer, Manufacturing
Core
Lead continuous improvement and process validation for THV delivery system manufacturing, ensuring operational efficiency and compliance.
Role type
Senior Manufacturing Engineer (Continuous Improvement & Validation)
Builds
THV delivery systems
Domain
Medical device manufacturing
Required skills
Lean Six Sigma, Design of Experiments (DOE), Statistical Process Control (SPC), Root Cause Analysis, CAPA management, Project Management, Equipment Qualification, Process Validation, Risk Management, FDA Regulations Knowledge
Preferred skills
PMP certification, Medical device industry experience, Automated production systems experience, New product transfer experience, Cross-functional project leadership
Technologies
Microsoft Project, Microsoft Excel, Microsoft PowerPoint
Responsibilities
Lead implementation of manufacturing process optimizations using engineering methods; Develop and execute complex experiments to qualify and validate processes; Analyze and resolve complex manufacturing and compliance issues; Develop training and documentation for production; Lead project plans to ensure deliverables meet customer expectations; Oversee manufacturing support tasks and train technicians.