Sr. Pr. R&D Coordinator
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Job Location:
Maple Grove, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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 peoples 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 .
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. Teleflexs 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
Associates 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.
#LI-NR1
Working Conditions / Physical Demands
The pay range for this position at commencement of employment is expected to be between ($) 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.
At Teleflex we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age race religion color national origin ancestry sexual orientation disability nationality sex or veteran status. If you require accommodation to apply for a position please contact us at: or
Teleflex the Teleflex logo Arrow Barrigel Deknatel LMA Pilling QuikClot Rüsch UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries.
2025 Teleflex Incorporated. All rights reserved.
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, w ... View more
