Sr. Manufacturing Engineer

Responsibilities: Provides daily support of products, processes, materials, and equipment to achieve production goals. Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Troubleshoot, repair, qualify or validate new and existing equipment used to manufacture endovascular catheters. Prepare testing and justification to support process, equipment and material changes. Determine appropriate level of testing required per internal procedures, customer alignment and regulatory acceptance requirements provided. Work with purchasing to optimize supply chains, recommend projects which reduce risk and/or reduce cost, and develop long-term commodity strategies. Design, implement and monitor Statistical Process Monitoring system Monitors daily yields and acts immediately to investigate and resolve issues to meet scrap and output goals. Designs, procures, and fabricates equipment tooling and fixtures. Performs troubleshooting on existing products/process problems as related to design, material, or processes. Prepares validation protocols and reports to communicate results and conclusions. May lead cross-functional project teams. Identifies, implements, and manages equipment, labor and cycle time requirements to support production goals. Trains and/or provides work direction to operators/technicians. May perform or support TMV's. Identify/Investigate Manufacturing issues (non-conformances) with root cause analysis and disposition production material through NCMR Process. Responsible for notifying QA/QC of any observed or reported product quality issues so that appropriate action may be taken. 4+ years of relevant experience overall and 2+ years of experience within medical device manufacturing. Familiar with catheter product design, manufacturing processes and applications. Summarizes, analyzes, and draws conclusions from test results. Ability to work successfully in cross-functional teams.