Senior R&D Coordinator
Teleflex
full-time
Posted on:
Location Type: Office
Location: Maple Grove • Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $82,600 per year
Job Level
Senior
Tech Stack
AssemblyOracle
About the role
- 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 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.
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.
- Advanced knowledge of technologies related to catheter design and construction, such as extrusion, injection molding, adhesive, thermal bonding, welding, core winding, and reflow processing.
- Working knowledge and experience implementing Good Manufacturing Practices (GMP) ISO13485 and FDA Quality Systems.
- Strong understanding of catheter or device assembly methods (extrusion, thermal bonding, molding, etc.)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
process oversightassembly techniquesprocess optimizationcalibrationmaintenancequalification recordsdesign verificationprocess validationdata-driven problem solvingcatheter design
Soft skills
trainingmentoringcoordinationcommunicationcontinuous improvementtroubleshootingleadership
Certifications
ISO 13485FDA complianceGood Manufacturing Practices (GMP)