Senior Engineer - Lean Manufacturing - Ave Maria, FL.
ArthrexAbout the role
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is currently seeking a Senior Lean Manufacturing Engineer , to help the business achieve production goals, cost reduction targets, and growth strategies by managing Safety, Quality, Delivery and Cost. Drive waste reduction efforts across assigned area. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™, located at our Ave Maria, FL manufacturing site.
First Shift – 8:00am -5:00pm, Monday- Friday
Essential Duties and Responsibilities:
- Maintain Managing for Daily Improvement (MDI) boards in assigned area and coordinate resources across the business to drive timely solutions.
- Create standard work, perform line balancing, write work instructions/training material, and perform training for continuous improvement and new product introductions.
- Provide Engineering with router data developed during the creation of standard work and line balancing.
- Work with Quality to identify and implement inspection methods.
- Work with Quality, Operations, and Planning to create Rework Addendums in response to NCR Rework dispositions.
- Create requirements and coordinate effective implementation with Engineering and outside vendors of equipment, tooling, and fixtures.
- Act as liaison between Finance, Engineering, Facilities, and Materials/Supply Chain to develop business case rationale for engineering projects and to coordinate the MOC (Management of Change) process.
- Act as a liaison between the AMI Engineering teams, INC Supply Chain, and INC product design and packaging design during request for pre-production samples (prototype, EGP-, pre V&V, V&V).
- Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies
- Work with Operations Excellence to schedule kaizen events targeting issues identified on MDI boards and new products/processes.
- Review product documentation for accuracy and completeness (BOMs, Routers, Assembly Drawings, Packaging Instructions, Component Drawings, Inspection Process Sheets, etc.).
- Evaluate and approve engineering changes prior to implementation on plant floor.
- Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
- Evaluate the impact of corrective maintenance (repairs) and perform Verification Studies as needed.
- Provide data for financial analysis for Make/Buy decisions.
Education/Experience:
- Bachelor’s degree in Engineering discipline required
- Experience in medical device manufacturing or other health sciences industry preferred
- Minimum of 5 years of relevant professional experience required
- SAP, miniTab, Solidworks experience preferred
- Experience working in a Cleanroom or controlled environment preferred
- Proven experience leading process improvement projects
- Lean Six Sigma Green Belt certification preferred
Skills:
- Advanced proficiency of MS Office programs required
- Ability to run PowerBI reports and analyze data
- Advanced ability to navigate SAP, Documentum, and Agile required
- Advanced ability to open, view and modify drawing specifications using a CAD program
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