Date: Mar 16, 2020
Location: Morrisville, NC, US
Expected Travel: Up to 10%
Requisition ID: 2326
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.
Surgical - Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our MiniLap Percutaneous Surgical System to Weck Hem-o-lok Polymer Locking Ligation System, and Weck EFx Shield Fascial Closure System, our portfolio of products adds up to a powerful offering of solutions that helps improve patient outcomes.
These innovative, minimally invasive surgery products are offered alongside time-tested and trusted Pilling Surgical Instrument and Lightsource solutions to provide a comprehensive set of solutions to meet the challenges of an evolving healthcare environment. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
This position will provide project engineering support for medical device projects. The candidate will collaborate with cross-functional development teams that are tasked to complete project activities within the communicated time, budget, and performance.
Key activities will include: Project planning, project budget management, product design support, cross-functional team alignment, DHF creation & updates, change control, and overall design control execution from concept to production. This individual will learn about the breadth of product development activities from conceptualization to manufacturing.
1.Assist with the development of project plans for existing product support and new product launches. This includes generating timelines that are developed with the cross-functional team and establishing the resource requirements to ensure that the project milestones are achieved.
2.Develop engineering documentation in order to produce various products. This includes the ability to generate quality & risk documents, test procedures, Verification and Validation plans, change control, and work with cross functional team members to establish and maintain the Design History File (DHF).
3.Support the design control team and be responsible for all documentation required to document design control process.
4.Support product design with concept generation, problem solving, CAD and development from concept to transfer.
5.Communicate effectively with all people at all levels of the organization to get projects completed, involving those not directly responsible for product launches.
6.Support product and process development activities as required to complete programs.
7.Work with marketing to translate customer requirements into tangible requirements
8.Assist with design of new product concepts based on customer requirements.
9.Support the development of tangible/testable requirements and specifications.
Work directly with RA to complete/satisfy all design control deliverables required for the communicated regulatory strategy and submissions
Work with Quality Engineering to complete Design FMEA(s) and drive cross-functional participation for these documents
Learn key aspects of supply chain, demand planning, purchasing, manufacturing, and inspection requirements for assigned Surgical products.
Support the execution of SOP(s) for:
1.TMV(s) (Test Method Validation)
2.Real Time Aging retention, testing
3.V&V testing, documentation
4.Change Control documentation
5.Testing protocols and reports
Become fluent in SAP/Agile systems and ensure all components and documents are properly coded in the TFX system.
Become current with all internal and appropriate external developments and policies in related areas of activity.
Provide other department support as requested by immediate supervisor or senior management.
Interface with vendors and manufacturing as required when implementing new designs.
Support New Product Introduction (NPI) in Design for Manufacture (DFM), sterilization methods, cost analysis, manufacturing optimization, and Design Transfer activities as required.
Learn about intellectual property generation and strategy for new and existing designs.
Education / Experience Requirements
1.Bachelor's degree in Engineering / Technology or Associate's degree in Engineering / Technology with 2+ years' experience with medical devices.
2.Basic CAD skills (SolidWorks preferred)
3.Prefer experience with project management using Microsoft Project.
4.Prefer general understanding of manufacturing operations.
5.Prefer working knowledge of medical device sterilization requirements and techniques.
6.Prefer understanding of GMP / FDA / ISO work environment.
7.Prefer understanding of ISO and ASTM testing methods for medical devices.
8.Prefer understanding of the Design Control Process.
9.Prefer knowledge of validations of processes and designs.
Specialized Skills / Other Requirements
Includes the following: Other duties may be assigned.
This position will provide project management, product design, and design control support within the Surgical Business Unit for product development projects. The candidate will perform duties to assure critical project and/or design control requirements are established and met within a defined timeframe.
This individual must be an effective communicator with a desire to develop organizational influence and effectiveness. The ideal candidate would possess an awareness of medical device products and medical device regulations.
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: 262-439-1894.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.