Manufacturing Engineer

3 days ago

Minneapolis, Minnesota, United States Teleflex Full time
Job Description

This is a hands-on engineering position that will provide technical support and operating knowledge for our medical device manufacturing. The successful candidate will take a key role in engineering functions such as validating and troubleshooting processes, as well as identifying and implementing process improvements.

Key Responsibilities
  • Support manufacturing processes related to catheter manufacturing in a cleanroom environment, as well as upstream processes including extrusion, molding, and braiding.
  • Attend daily Value Stream meetings and present updates on engineering activities.
  • Lead continuous improvement projects focused on scrap reduction and increasing efficiency.
  • Create, maintain, and update manufacturing and inspection documentation, executing document changes according to Quality Management System procedures.
  • Coordinate and manage projects in support of product transfers, including procuring equipment, capacity review, process improvements, and lead training efforts for new processes.
  • Review critical internal and external product requirements with R&D and Product Development to ensure design for manufacturability on new products in development.
  • Write and perform equipment and process qualifications (IQ/OQ/PQ).
  • Develop Control Plans, Gage R&R's, Test Method Validations, and pFMEA.
  • Troubleshoot product defects and variation, perform root cause analysis, apply systematic problem-solving skills, and build robust solutions.
  • Create equipment user requirement specifications, obtain quotes from internal and/or external vendors, manage capital requests, verify functionality of equipment, and implement equipment into production.
  • Identify, design, and implement fixtures to aid in the manufacturing and inspection processes.
  • Serve as a Subject Matter Expert (SME) in core manufacturing processes as assigned.
  • Mentor and assist engineers, technicians, and interns.
  • Perform other related duties and responsibilities as assigned.
Requirements
  • Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical, or Mechanical Engineering, or a related technical field.
  • A minimum of 2 years of experience in a manufacturing environment, preferably in the medical device manufacturing industry or other heavily regulated industry.
  • Experience in catheter manufacturing or development is preferred.
Specialized Skills
  • Working knowledge of manufacturing processes related to catheter production, molding, and extrusion.
  • Good mechanical aptitude and ability to learn equipment operation, with machine maintenance support where required.
  • Experience with Lean Manufacturing and Continuous Improvement methodologies.
  • Six Sigma Green belt certification is preferred.
  • Excellent oral and written communication skills, with the ability to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations.
  • Experience with Microsoft Word, Excel, and PowerPoint is required, with experience with Microsoft Project, Visio, and Minitab preferred.
  • Experience using statistical methods for data analysis is preferred.
  • Working knowledge of GD&T with proficiency in SolidWorks or comparable CAD software.
  • Ability to prioritize, work independently, and manage multiple projects and responsibilities.
  • Experience with Design Controls, FDA regulation, Good Manufacturing Practices, and Quality System Requirements.
  • Behaviors consistent with a safety and quality-driven culture.
  • Demonstrates Teleflex Core Values: People, Entrepreneurial Spirit, Building Trust, Make it Fun.

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