Expected Travel: Up to 10%
Requisition ID: 6075
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
This hands-on Engineering position will provide TFX Medical with technical support and operating knowledge for our medical device operation. This person will take an important 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 or materials. This position will focus on value stream support to improve yields, resolve material issues, customer complaints, waste reduction, 5s process improvements utilizing automation and material flow enhancements to produce a higher quality product faster.
• Develop, support, and troubleshoot manufacturing processes related to catheter manufacturing in a cleanroom environment as well as upstream processes.
• 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.
• Support Process FMEAs and production transfer documentation.
• Provide support to R&D, manufacturing, marketing, and customer service as well as interface with customers and suppliers.
• Review critical internal and external product requirements with product development to ensure design for manufacturability.
• Conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/OQ/PQ/TMV).
• Utilize root cause analysis tools for non-conformance investigations and implementation of corrective actions.
• Create equipment user requirement specifications, obtain quotes from internal and/or external vendors, manage capital requests, and verify functionality of equipment.
• Identify and implement process improvements utilizing lean principles.
• Properly update and document process according to QMS standards.
• Lead Value Stream meetings for engineering activities.
• Identify, design, and implement fixtures to aid in the manufacturing process.
• Other duties as assigned.
Education / Experience Requirements
• Bachelor's degree in engineering, required. Bachelor's degree in Plastics, Chemical, Biomedical, or Mechanical Engineering, preferred.
• 3-5 years of experience in manufacturing environment, required. Medical catheter manufacturing experience and/or process development experience, preferred.
• Experience in medical device manufacturing industry or manufacturing in a regulated manufacturing environment (ISO, FDA, etc.) preferred.
Specialized Skills / Other Requirements
• Good mechanical aptitude able to learn equipment and their operation. Machine maintenance support where required.
• Lean manufacturing experience and Continuous Improvement methodology.
• Experience with product transfers from development into production.
• Experience using statistical methods. Proficient in Minitab or comparable statistical software preferred.
• Experience writing and performing qualifications of equipment, product, and processes.
• Experience with lean six-sigma manufacturing and preferably, green-belt certified.
• Proficient in Solidworks and or comparable CAD software.
• Excellent oral, written communication and presentation skills.
• Ability to prioritize, work independently and manage multiple projects and responsivities.
• Familiar with design controls, FDA regulation, and Good Manufacturing Practices.
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.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2021 Teleflex Incorporated. All rights reserved.
Edward D. Jones
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