Develops, implements and maintains methods, operation sequence and processes in the manufacturing of parts, components, sub-assemblies and final assemblies. This position will be responsible for supporting new initiatives and productivity targets for post processing and Porous PEEK manufacturing processes. Responsibilities will also include participation in design reviews, design transfer to production as it relates to development of manufacturing processes, post processing development, equipment and process validations, process definition for machine operation and maintenance requirements, test/inspection methods, fixturing, gauging and applying inspection and process control techniques. Performs duties in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, and the European Medical Device Directive.
Take ownership of Porous PEEK project success for new and existing families of production.
Coordinate cross-functional teams to execute and document the manufacturing launch of new/legacy products.
Support the development and optimization of manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning and shipment.
Interface 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).
Drive machine/equipment efficiency thru cycle time reduction, waste elimination, tooling improvements, and changeover reductions.
Execute the Engineering Change Process for process updates and improvements.
Proven ability to define problems, collect data, establish facts, and implement effective solutions.
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.
Support 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 performance metrics and KPIs.
Participate in non-conforming material review process by supporting containment and review activities, root cause analysis, driving production disposition, and implementing corrective and preventative actions.
Bachelor's degree (BS) in an engineering discipline or associate's degree in a technical field with 5+ years experience in technical manufacturing role.
Proficient in Microsoft suite
Proven ability and fluency in Print Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma, and Gage/fixture design
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The "EEO is the Law" poster options are available