Process Engineer

Process Engineer

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

Position Summary

The Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative way to achieve the company's goals of producing market leading products through positive patient outcomes.

Essential Functions Of The Position:

• Team member of projects involving design and manufacturing resources, both internal and external.
• Ownership of product assembly line technical performance.
• Support production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA's.
• Drive a lean, KPI-driven, and continuous improvement culture across the department.
• Implement lean principles and methodologies to optimize manufacturing processes.
• Lead continuous improvement initiatives, including value stream mapping (VSM), 5S and Kaizen events.
• Analyze production data to identify bottlenecks, inefficiencies, and opportunities for streamlining.
• Collaborate with cross-functional engineering team (quality, product development, regulatory) to address product line issues.
• Responsible for communication of manufacturing and process issues to cross functional engineering team and suppliers, both verbally and in written documentation.
• Review of proposed component tolerances and input to manufacturing capability.
• Has knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc.
• Understands GD&T and how to properly apply it to yield the desired fits between joining parts.
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
• Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, soldering etc.
• Understand of error proofing, poke-yoke.
• Working knowledge of Manual and Automated Assembly Systems and Technologies.
• Act as a lean champion to train and mentor others on lean concepts and tools as needed.

Manufacturing Process Knowledge

Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume manufacturing processes. Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, using SPC in resolving/improving productivity and efficiencies etc. Work with outside suppliers to define, document, analyze and qualify their manufacturing processes. Identify new vendors, processes, materials, and technologies that ca