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- 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.
- bility to work successfully in cross-functional teams.
Sr. Manufacturing Engineer - Brooklyn Park, United States - Katalyst Healthcares and Life Sciences
