Senior Industrial Engineer I
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 actively searching for a Senior Industrial Engineer I to support our Pendleton, SC manufacturing facility. This position requires a Bachelor’s degree in Engineering or Engineering Technology along with five (5) or more years of relevant, post education working experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Main Objective:
Increase the productivity of inventory, material handling systems, and manufacturing operations to help the business achieve production goals, cost reduction targets, and growth strategies. Drive scrap/waste reduction efforts across all Final Assembly, Packaging, and Labeling Operations.
Essential Duties and Responsibilities:
- Discover opportunities for waste reduction and capacity improvement and proactively drive solutions with and without capital investment.
- Act as liaison between Finance, Engineering, Facilities, and Materials/Supply Chain and to develop business case rationale for engineering projects and to coordinate the MOC (Management of Change) process for the department.
- Facilitate kaizen events targeting key improvements to drive productivity, data management/collection, business process, and paperwork handling improvements.
- Develop and implement systems and improvement strategies for direct material flow (in plant transport, inventory staging/access, and assembly line supply).
- Evaluate process improvements for operations (labor balancing, time studies, line setup, error proofing, assembly methods, etc.) to minimize downtime and rework.
- Provide financial analysis for Make/Buy decisions in support of continuous improvement projects.
- Coordinate equipment / process changes on assembly lines.
- Review product documentation for accuracy and completeness (BOMs, Routers, Work Instructions, Assembly Drawings, Packaging Instructions, Component Drawings, Inspection Process Sheets, etc.).
- Create and manage production routers and MRB related rework processes.
- Evaluate and approve engineering changes prior to implementation on plant floor.
- Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
- Assist with annual budget preparation.
Education and Experience:
- Bachelor’s degree in Industrial Engineering or other Engineering discipline required.
- Minimum of 5 years of relevant professional experience required.
- Experience in medical device manufacturing or other health sciences industry preferred.
- Experience working in a Cleanroom or controlled environment preferred.
- Proven experience leading process improvement projects.
- Experience in workflow optimization, work measurement, efficiencies.
- Lean Six Sigma Green Belt/ Black Belt certification preferred.
- SAP, miniTab, Solidworks experience preferred.
- Project Management Professional training/certification preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Advanced proficiency of MS Office programs required.
- Ability to create PowerBI reports preferred.
- Advanced ability to navigate SAP, Documentum, and Agile required.
- Advanced ability to open, view and modify drawing specifications using a CAD program.
- Advanced knowledge of administrative procedures and computer systems.
- Basic knowledge of ISO 13485 and FDA 21 CFR Part 820 as related to cGMP.
- Advanced experience using Project Management software tools (Mindview, MS Project, Workfront).
- Advanced knowledge and experience in designing and conducting time studies, work sampling studies, value stream mapping, designing Poka Yoke fixtures and capacity modeling.
- Advanced ability to analyze data and process inputs to justify improvements and mitigate variances.
- Ability to create a designed experiment (DOE), collect the data, and analyze the data.
- Advanced knowledge of Statistical Analysis techniques and software (miniTab) and Statistical Process Control (SPC) preferred.
- Advanced ability to lead/manage a large-scale process improvement project involving new capital equipment (MOC).
- Advanced experience preparing a capital equipment budget and justification (ROI).
- Advanced knowledge and experience applying Continuous improvement methods (Lean, Six Sigma).
- Experien
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