Sr. Pr. R&D Coordinator

Expected Travel: Up to 10%

Requisition ID: 13152

 

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  For more information, please visit teleflex.com.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist.  Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner™ and Turnpike™ Catheters, Ringer™ Perfusion Balloon Catheter, AC3 Optimus™ and AC3 Range™ Intra-Aortic Balloon Pumps and the OnControl™ Powered Bone Access System. Teleflex’s product portfolio now also includes Passeo™-18 Lux™ Peripheral Drug-Coated Balloon Catheter, Pantera™ Lux™ Drug-Coated Balloon Catheter, Orsiro™ Mission™ Drug-Eluting Stent, the PK Papyrus™ Covered Coronary Stent, and more.  With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Senior R&D Coordinator supports the design, development, testing and pilot-scale manufacturing of new and existing medical devices. This role coordinates and leads daily operations within R&D cleanroom, ensuring effective engineering builds, compliance with ISO and FDA requirements and seamless coordination between R&D and manufacturing functions. The position provides technical leadership to cleanroom personnel and plays a key role in scaling products from early development through design transfer.

Principal Responsibilities

•    Coordinate and lead activities of the R&D cleanroom, including build execution, operator scheduling and process oversight.
•    Train and mentor operators on assembly techniques and documentaion requirements.
•    Partner with engineering teams to ensure pilot line readiness and process optimization.
•    Ensure ISO 13485, FDA, and GMP compliance across all pilot line activities.
•    Maintain calibration, maintenance, and qualification records of cleanroom pilot line equipment.
•    Implement 5S and safety continuous improvement initiatives within R&D labs and cleanrooms 
•    Coordinates engineering design verification and process validation builds, ensuring quality, traceability and on-time completion.
•    Creates and maintains manufacturing documentation within quality systems.
•    Manages traceability of raw materials and components 
•    Serve as liaison between R&D engineering, manufacturing, and quality teams.
•    Support design transfer to production through documentation, training, and validation support.
•    Participates in root cause and risk analysis 
•    Identify and troubleshoot process outputs, quality defects, and manufacturing challenges.  
•    Lead and execute pilot line continuous improvement strategies to improve quality, reduce cost, minimize waste, and increase throughput.  

Education / Experience Requirements

•    Associate’s or technical degree in Engineering, Manufacturing, or related field preferred.
•    Minimum 10 years of experience in R&D or manufacturing support for medical devices.
•    Experience with Oracle Agile, SAP, and cleanroom manufacturing processes preferred.

Specialized Skills / Other Requirements

•    Proficient in MS Office, Minitab and data-driven problem solving. 
•    Excellent oral and written communication skills. Proficient at communicating effectively across functions to achieve common goals.
•    Ability to manage dynamic workload and prioritize small and large tasks efficiently.
•    Working knowledge and experience implementing Go