Sr. Pr. R&D Coordinator

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 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.
COMPETENCIES - incumbent must have proven abiilty to:
•    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.

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($82,600,123,900)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.