Sr. Pr. R&D Coordinator

Teleflex Incorporated-posted about 17 hours ago
Full-time • Mid Level
Maple Grove, MN
5,001-10,000 employees
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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 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.
  • 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) ISO13485 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 ISO9000, 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 implement 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.
  • Instills Trust: Demonstrates integrity, reliability, and consistency in all actions.
  • Courage: Addresses difficult issues constructively and provides direct, actionable feedback.
  • Decision Quality: Makes sound, timely decisions based on available data and risk considerations.
  • Plans and Aligns: Effectively prioritizes and executes work to meet organizational and project goals.
  • Cultivate Innovation: Encourages creative problem-solving and new approaches to improve processes.
  • Optimizes Work Processes: Continuously evaluates and improves workflows for efficiency and quality.
  • medical
  • prescription drug
  • dental and vision insurance
  • flexible spending accounts
  • participation in 401(k) savings plan
  • various paid time off benefits, such as PTO, short- and long-term disability and parental leave
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