Sr. Pr. R&D Coordinator

Teleflex is a global provider of medical technologies, focused on improving health and quality of life. For more information, visit .

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.

• 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 documentation 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 clean rooms.
• Coordinate engineering design verification and process validation builds, ensuring quality, traceability and on‑time completion.
• Create and maintain manufacturing documentation within quality systems.
• Manage 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.
• Participate 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.

• 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.

• 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 Good Manufacturing Practices (GMP), ISO 13485 and FDA Quality Systems.
• Advanced knowledge of technologies related to catheter design and construction such as extrusion, injection molding, adhesive, thermal bonding, welding, core winding and reflow processing.
• Experience with and working knowledge of ISO 9000 and FDA requirements.
• Working knowledge of mechanical drawings, product requirements and engineering specifications.
• Attention to detail. Ability to manipulate small pieces of data with accuracy and focus, identifying information that does not fit and implementing solutions.
• High mechanical aptitude and problem‑solving/decision‑making skills. Ability to think critically and implement solutions independently.
• Strong understanding of catheter or device assembly methods (extrusion, thermal bonding, molding, etc.).
• Demonstrated leadership of small technical teams.
• Competencies:
  
  Instills Trust – Demonstrates integrity, reliability and consistency in all actions.
• Competencies:
  
  Courage – Addresses difficult issues constructively and provides direct, actionable feedback.
• Competencies:
  
  Decision Quality – Makes sound, timely decisions based on available data and risk considerations.
• Competencies:
  
  Plans and Aligns – Effectively prioritizes and executes work to meet organizational and project goals.
• Competencies:
  
  Cultivate Innovation – Encourages creative problem‑solving and new approaches to improve processes.
• Optimizes Work Processes – Continuously evaluates and improves workflows for efficiency and quality.

The pay range for this position at commencement of employment…