Engineer I - Advanced Manufacturing (Electrical)- Ave Maria, FL.

 Requisition ID:                       63390                          Title: Engineer I - Advanced Manufacturing (Electrical)- Ave Maria, FL. 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 an Advanced Manufacturing Engineer- Electrical, to provide process engineering support to AMI Packaging Operations (Ex. Laser Mark/Weld, Passivation, Cleaning, Device Assembly, Packaging, Boxing) and INC Product Design teams to achieve business goals.  To lead the electrical design and programming of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing.  To implement electrical hardware and software/programming solutions to improve safety, quality, and efficiency of manufacturing processes. To implement solutions to improve data collection and analytics of manufacturing equipment. 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. 

 

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 electrical controls and programming.
• Maintain compliance with Safety requirements related to equipment access controls, electronic safety features, and interlocks.
• Maintain compliance with Medical Device Quality System requirements related to equipment and software validation (CSV).
• Design and develop electrical/controls solutions for custom automation or semi-automated equipment or fixturing.
• Design and develop custom electrical/functional testing systems for electro-mechanical medical devices.
• Identify and evaluate the optimum electrical controls and software solutions 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
• Engineering Co-Op or internship experience preferred.
• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.

 

Skills:

• Basic knowledge of Materials and Machine d