R&D Document Specialist II

Date: May 17, 2024

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 10227


About Teleflex Incorporated

Teleflex is a global provider of clinically effective 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, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.


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, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. 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 R&D Document Specialist plays a crucial role in ensuring the efficient management of Teleflex products, throughout the various stages of Product Lifecycles Management (PLM) for R&D.  This role is focused on meticulously preparing, evaluating, and expediting R&D documents using Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) systems. The specialist ensures R&D documents are complete, accurate, and compliant within these systems, serving as a Subject Matter Expert (SME) for R&D in PLM and document control processes.

Principal Responsibilities

•    R&D Subject Matter Expert in document change control in PLM systems
•    Partner with R&D to facilitate and guide ECO/COs in preparing, routing, approval, and release of documentation in QMS/ERP systems.
•    Support creating New Product Development (NPD) documentation in QMS/ERP systems for R&D projects. 
•    Identify and implement best practices in document control, and drive continuous improvements for R&D NPD projects.
•    Create detailed reports and queries for ECO/CO, accuracy, approvals, and throughput in QMS for R&D. 
•    Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements in PLM document control systems.
•    Generate, assign, update, and ensure accuracy of the Global Trade Identification Number (GTIN) information in applicable systems.
•    Participate in problem solving, metric reporting/improvement, and other various projects, as assigned.
•    Provide high-level customer service and support to specific cross-functional areas.
•    Participate in and/or lead special projects, as assigned.
•    Provide audit and training support, as requested.

Note: 75% of this job involves direct R&D activities

Education / Experience Requirements

•    Bachelor’s or technical degree in related field, degree preferred.  
•    3 + years of experience in design and development of medical devices
•    5 + years of experience in document control using PLM and ERP software, Oracle Agile/SAP preferred.
•    Working knowledge of Microsoft Word, Excel, Outlook, Adobe Acrobat

Specialized Skills / Other Requirements

  • Excellent written and oral communication skills
  • Detail oriented and self-directed with excellent time management skills
  • Advanced knowledge working in quality systems and compliance processes in a regulated industry
  • Advanced knowldege and skills and using PLM and ERP softwares
  • Proven ability to work collaboratively and independently
  • Autonmy and experiece to effectively poritize and execute projects/tasks with minimal oversight


The incumbent must have proven abiilty to:
•    Instills Trust - Gains the confidence and trust of others through honesty, integrity, and authenticity. Follows through on commitments; is seen as direct and truthful; keeps confidences; practices what he/she teaches; shows consistency between words and actions.
•    Courage - Steps up to address difficult issues, saying what needs to be said. Readily tackles tough assignments; faces difficult issues and supports others who do the same; provides direct and actionable feedback; is willing to champion an idea or position despite dissent or political risk.
•    Decision Quality - Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information.
•    Plans and Aligns - Plans and prioritizes work to meet commitments aligned with organizational goals. Sets objectives to align with broader organizational goals; breaks down objectives into appropriate initiatives and actions; stages activities with relevant milestones and schedules; anticipates and adjusts effective contingency plans.
•    Cultivates innovation - Creates new and better ways for the organization to be successful. Comes up with useful ideas that are new, better, or unique; introduces new ways of looking at problems; can take a creative idea and put it into practice; encourages diverse thinking to promote and nurture innovation.
•    Optimizes Work Processes - Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Identifies and creates the processes necessary to get work done; separates and combines activities into efficient workflow; designs processes and procedures that allow managing from a distance; seeks ways to improve processes, from small tweaks to complete reengineering.

Working Conditions / Physical Demands

•    Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
•    Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required
•    Ability to communicate clearly both in writing and using spoken communication, with or without assistance
•    Ability to read, comprehend, and appropriately act upon detailed written information at an advanced level, with or without assistance
•    Infrequent lifting of up to 20 pounds may be required

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

Nearest Major Market: Boston