Sr. R&D Coordinator jobs in United States
cer-icon
Apply on Employer Site
company-logo

Teleflex · 23 hours ago

Sr. R&D Coordinator

Teleflex is a global provider of medical technologies aimed at improving health and quality of life. They are seeking a Sr. R&D Coordinator to support the design, development, testing, and manufacturing of medical devices, ensuring compliance with ISO and FDA requirements while leading operations in the R&D cleanroom.

CommercialHealth CareMedicalMedical Device
check
H1B Sponsor Likelynote

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 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

Qualification

R&D cleanroom operationsISO 13485 complianceFDA Quality SystemsOracle AgileSAPGMP implementationData-driven problem solvingMS OfficeMinitabMechanical aptitudeCommunication skillsLeadership skills

Required

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
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

Preferred

Experience with Oracle Agile, SAP, and cleanroom manufacturing processes preferred

Benefits

Medical
Prescription drug
Dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits
PTO
Short- and long-term disability
Parental leave

Company

Teleflex

company-logo
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.

H1B Sponsorship

Teleflex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$400M
2016-05-12Post Ipo Debt· $400M
1990-01-01IPO

Leadership Team

leader-logo
Liam Kelly
Chairman, President and CEO
linkedin
leader-logo
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
linkedin
Company data provided by crunchbase