Sr. R&D Document Specialist
Listed on 2026-08-26
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Engineering
Biomedical Engineer, Quality Engineering, Regulatory Compliance Specialist, Medical Device Industry
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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's 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™, Quik Clot™, Rüsch™, Uro Lift™ 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 .
InterventionalThe Interventional business unit at Teleflex develops innovative medical devices used to diagnose and treat coronary and peripheral vascular diseases. We focus strategically on coronary and peripheral interventions, vascular and bone access, and large-bore closure solutions.
Our portfolio includes a broad range of clinically relevant products, such as the Guide Liner™ and Turnpike™ Catheters; the Orsiro™ Mission™ Drug-Eluting Stent; the PK Papyrus™ Covered Coronary Stent; the Ringer™ Perfusion Balloon Catheter; the Pulsar™
-18 T3 Self-Expanding Stent;
Passeo™ Balloon Catheters; and the OnControl™ Powered Bone Access System.
Backed by a strong R&D pipeline, our rapidly growing Interventional business unit is well positioned to continue advancing new technologies that support the treatment of critically ill patients. Join a dynamic team dedicated to delivering innovative medical solutions that make a meaningful difference in patients’ lives.
Position SummaryThe Senior R&D Document Specialist serves as the subject matter expert for R&D document control, Product Lifecycle Management (PLM), and engineering change processes. This role ensures the accuracy, completeness, compliance, and timely release of product documentation throughout the product lifecycle. Working closely with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain, the Senior Specialist provides technical leadership, drives process improvements, and supports successful product development and commercialization through effective management of engineering documentation within PLM, QMS, and ERP systems.
The Senior R&D Document Specialist serves as the subject matter expert for R&D document control, Product Lifecycle Management (PLM), and engineering change processes. This role ensures the accuracy, completeness, compliance, and timely release of product documentation throughout the product lifecycle. Working closely with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain, the Senior Specialist provides technical leadership, drives process improvements, and supports successful product development and commercialization through effective management of engineering documentation within PLM, QMS, and ERP systems.
- Serve as the R&D Subject Matter Expert (SME) for document control, engineering change management, and Product Lifecycle Management (PLM) processes.
- Lead and facilitate engineering change orders (ECO/CO), ensuring documentation is complete, accurate, compliant, and progresses efficiently through review, approval, and release workflows.
- Ensure engineering documentation complies with applicable FDA, ISO 13485, MDR, and internal Quality System requirements.
- Partner with cross-functional teams to develop, maintain, and release complete Design History File (DHF) documentation supporting new product development and sustaining engineering.
- Ensure the integrity, accuracy, and consistency of engineering master data across PLM, ERP, and Quality Management Systems.
- Identify and implement best practices in document control, and drive continuous improvements for R&D NPD projects.
- Develop dashboards, reports, and performance metrics to monitor engineering change throughput, quality, cycle times, and process effectiveness to drive data-based decision making.
- Assist in monitoring process…
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