US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
As a Senior Manufacturing Engineer at NuVasive Manufacturing focused on project leadership, each day will offer new challenges as you tackle a variety of responsibilities to support the development, production, and commercial launch of medical devices. As a seasoned ME, you’ll take ownership of projects for new and existing products manufactured in our plant, specifically by determining manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning, packaging, and shipment. You’ll work with and lead cross-functional teams to execute and document the manufacturing launch of new/legacy products.
· Collaborate with Quality Engineering to determine critical manufacturing process and control characteristics.
· Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).
· Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.
· Execute the Engineering Change Process for process updates and improvements.
· Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency.
· Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.
· Coordinate and manage the estimating/quoting process.
· Lead design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development (Design) Engineers.
· Support process validation by working with validation engineers to clarify methods, inputs, and outputs of processes or equipment.
· Implement, maintain, analyze and react to various production data logs.
· Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions.
· Understand basic anatomy and physiology of the spine and procedures for which products will be designed and developed.
· Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.