Sr. Manufacturing Engineer

4 weeks ago

Brooklyn Park, United States Katalyst Healthcares and Life Sciences Full time
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.
Requirements:
  • 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.

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