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
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)
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)
Experience identifying Kaizen events
Experience leading A3 Process Improvements
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
Ability to apply structured problem solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods
Ability to work independently and effectively with cross functional teams
Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms
Ability to directly and effectively supervise junior level engineers and technicians
Knowledge:
Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
Reasoning Ability:
Develops solutions to a variety of complex problems. May refer to established precedents and policies.
Discretion/ Latitude:
Work is performed under minimal direction. Participates in determining objectives of assignment. Plans, schedules, and arranges own activities in accomplishing objectives with some coordination of team resources. Work is reviewed upon completion for adequacy in meeting objectives.
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.
