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 Lean Manufacturing Engineer II, 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
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 2 years of relevant professional experience required
SAP, miniTab, Solidworks experience preferred
Experience working in a Cleanroom or controlled environment preferred
Skills:
Intermediate knowledge of MS Office programs required
Ability to run PowerBI reports and analyze data
Intermediate knowledge of administrative procedures and computer systems
Basic knowledge of ISO 13485 and FDA 21 CFR Part 820 as related to cGMP
Ability to open and view drawing specifications using a CAD program
Intermediate knowledge of Project Management software tools (Mindview, MS Project, Workfront)
Intermediate 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
Ability to create a designed experiment (DOE), collect the data, and analyze the data
Intermediate knowledge of Statistical Analysis techniques and software (miniTab) and Statistical Process Control (SPC)
Intermediate ability to lead & manage a process improvement project
Intermediate knowledge and experience applying Continuous improvement methods (Lean, Six Sigma)
Advanced ability to assist in cost analysis and financial planning by estimating production labor and equipment costs
Advanced ability to develop the most efficient methods of utilizing people, machines, materials, information, and energy
Ability to create and maintain accurate pFMEAs for assigned processes
Advanced ability to work independently and effectively with cross functional teams
Advanced ability to communicate ideas, results, recommendations, and status effectively in oral and written forms
Knowledge:
Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
Reasoning Ability:
Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Discretion/ Latitude:
Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Mathematical Skills:
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear.
The employee is frequently required to stand for 8-10 hours per day wearing gowns, hairnets, and gloves; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 20 pounds. Must possess the dexterity to utilize writing utensils (pen/pencil), calculators, small hand-held tools, manual razors, and other mechanical/electrical equipment without assistance. Ability to work in close proximity to fellow teammates in cramped conditions.
Vision Requirements:
Visual acuity necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision using a microscope and light source
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
