Manufacturing Engineer

Position Summary

This hands-on Engineering position will provide Teleflex Medical with technical support and operating knowledge for our medical device manufacturing. This person will take a key role in engineering functions such as validating and troubleshooting processes as well as identifying and implementing process improvements. The engineer will support day-to-day production and the transfer of development projects into production. The engineer will also be required to work with internal and external vendors to design and specify tooling, fixturing and materials. This position will focus on value stream support to improve safety, quality, efficiency, and delivery of catheter manufacturing. 

Principal 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. Execute document changes according to Quality Management System procedures.
•    Coordinate and manage projects in support of product transfers, including but not limited to 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.
•    SME in core manufacturing processes as assigned.
•    Mentor and assist engineers, technicians, and interns.
•    Perform other related duties and responsibilities, as assigned.
 

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering, or related technical field is required. 
•    A minimum of 2 years of experience in manufacturing environment is required. Medical Device manufacturing industry or other heavily regulated industry is preferred. 
•    Experience in medical device manufacturing industry or manufacturing in a regulated manufacturing environment (ISO, FDA, etc.) is required.
•    Experience in catheter manufacturing or development is preferred.
 

Specialized Skills / Other Requirements

•    Working knowledge of manufacturing processes related to catheter production, molding, and extrusion. 
•    Good mechanical aptitude and able to learn equipment operation. Machine maintenance support where required.
•    Experience with Lean Manufacturing and Continuous Improvement methodologies.
•    Six Sigma Green belt certification preferred. 
•    Excellent oral and written communication skills are required. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations.
•    Experience with Microsoft Word, Excel and PowerPoint is required. Experience with Microsoft Project, Visio, and Minitab is 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 to support a safety and quality driven culture.
•    Demonstrates Teleflex Core Values; People, Entrepreneurial Spirit, Building Trust, Make it Fun. 
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Working Conditions / Physical Demands

•    Exposure to high production/output machinery and equipment, and constant noise in the production/plant environment. 
•    Consistent lifting: 2 - 20 lbs. necessary/ Max = 50 lbs.
•    Engages in walking, sitting, lifting, bending, carrying, talking, and hearing.