Senior Manufacturing Process Engineer II - Ave Maria, FL.

 Requisition ID:    61044                          Title: Senior Manufacturing Process Engineer II - 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 a Senior Manufacturing Process Engineer II, 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 projects involving: rapid commercialization of new products; commercialization of new laser, passivation, cleaning, assembly, and mechanized equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. 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:

• Support new product development/design transfer by leading process development and validation. 
• Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost.
• Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency.
• Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes.
• Lead the design, development, and commercialization of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Design, develop, and manage tooling and fixtures.  Coordinate quotes and procurement of new tooling with vendors.  Assess and execute validation requirements accordingly.
• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
• Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.

• Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies.
• Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis.
• Ensure data and documentation are consistently accurate and complete.
• Applies statistical methods to estimate future manufacturing requirements and potential.
• Analyzes a