Engineer II - Lean Manufacturing- Ave Maria, FL.

Full-time - Mid Level

Ave Maria, FL

Miscellaneous Manufacturing

About the position

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.

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.

Requirements

• Bachelor's degree in Engineering discipline required.
• Minimum of 2 years of relevant professional experience required.
• Intermediate knowledge of MS Office programs required.
• Ability to run PowerBI reports and analyze data.
• 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 and experience applying Continuous improvement methods (Lean, Six Sigma).

Nice-to-haves

• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.
• Experience working in a Cleanroom or controlled environment preferred.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)