Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging)

Requisition ID:                       63860                          Title: Principal Advanced Manufacturing Engineer - Mechanical - Ave Maria, FL. (Packaging) Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL. 

 

 

 

 

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 Principal Advanced Manufacturing Engineer to provide process engineering support to AMI Packaging Operations (Ex. Laser Mark/Weld, Passivation, Cleaning, Component/Device Assembly, Packaging, Boxing) and INC Product Design teams to achieve business goals.  To lead the mechanical design and fabrication of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing.  To implement mechanical design solutions to improve safety, quality, and efficiency of manufacturing processes. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

First Shift - Monday- Friday, 8:00am-5:00pm 

 

Essential Duties and Responsibilities:

• Support a customer-focused culture by identifying key customer/user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
• Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean/Six Sigma continuous improvement tools in all projects.
• Support a highly innovative culture by identifying novel/first-of-a-kind solutions, and applying lessons learned through successes and failures.
• Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status escalating issues.
• Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment mechanical design and fabrication.
• Maintain compliance with Safety requirements related to ergonomics (human-to-machine interface) and guarding.
• Maintain compliance with Medical Device Quality System requirements related to equipment validation.
• Design and develop mechanical design solutions for custom automation or semi-automated equipment or fixturing.
• Design and develop custom poka yoke, Go/No-Go, and inspection gauges/fixtures as well as mechanical design of automated, inline inspectionand test systems for electro-mechanical medical devices.
• Identify and evaluate the optimum mechanical design solutions and equipment components based on the latest available technology and industry best practices.
• Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
• Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
• Create and execute validation protocols and reports compliant with Medial Device requirements (IQ, OQ, PQ).
• Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts.
• Create operator work instructions and troubleshooting guides.
• Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
• Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE’s)
•  Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
• May supervise Technician, Engineering, Prototype or Programming personnel.

 

Education/Experience:

• B.S. in Engineering required
• Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required.
• Proven Experience leading process improvement projects.
• Proven Experience leading new equipment, capital projects.
• Experience leading/ supervising direct reports.
• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.
• Lean Six Sigma Green Belt / Black Belt certification preferred.
• Lean Six Sigma Green Belt / Black Belt certification preferred. 

 

Skills:

• Expert knowledge of Materials and relevant Machine design/function. ·
• Expert knowledge of emerging technologies and applies them to current and new p