R&d Document Specialist Ii

3 weeks ago

Chelmsford, United States Teleflex Full time

**Date**:Apr 18, 2024

**Location**: Chelmsford, MA, US

**Company**:Teleflex

**Expected Travel**: Up to 10%

**Requisition ID**: 10227

**About Teleflex Incorporated**

**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 mínimal oversight
- Competencies- 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; c

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