Pr. R&D Coordinator

Teleflex•Maple Grove, MN

About The Position

The Principal 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.

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.
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.

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.