R&D Project Engineer - MDR

Date: Sep 1, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4565

 

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.

Position Summary

Responsible for planning and execution of product performance testing in accordance with Teleflex design control procedures and to meet EU Medical Device Regulation (MDR) requirements and deadlines. Participate and interface with project teams in order to execute the transition of Technical Files from the requirements of the Medical Device Directive (MDD) to the requirements of the Medical Device Regulation (MDR). Products affected will include all EU regulatory classifications, i.e. Class I, IIa, IIb and III. 

The candidate will participate in cross-functional reviews of the Technical Files to ensure all test requirements are being planned and executed in a timely manner. 
 

Principal Responsibilities

1.    Primary responsibility is to plan and coordinate activities of technical resources assigned to updating Technical Files and Design Dossiers in preparation for new MDR regulations. 
2.    Coordinate overall planning and resource allocation and activities to meet target dates as defined by the Business Unit (BU) regulatory lead.
3.    Generate test protocols, analyze test data, and generate written reports.
4.    Contribute to design documentation including input for the Design History File (DHF) and technical design reviews.
5.    For in-house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement components.
6.    Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as Design Of Experiment (DOE), accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
7.    Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
8.    Interface with suppliers to obtain information required to update Technical Files and DHF documentation. Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
9.    Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
10.    Lead and participate in design and technical phase reviews.
11.    Ensure projects are developed and documented compliant with the Teleflex Quality System.
12.    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    Bachelor of Science or Professional Engineer Certification -Engineering or technical discipline.
•    PMP certification preferred.
•    3+ years previous experience in related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation)

Specialized Skills / Other Requirements

1.    Orientation for detailed work with emphasis on accuracy and completeness
2.    Effective written and oral communication skills
3.    Good organizational and planning skills; drives for results
4.    Effective analytical/problem-solving skills
5.    Good interpersonal skills that include working well in a team environment and the ability to lead others.
6.    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
7.    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
8.    Working knowledge of international requirements and quality systems.
9.    Computer Literate: Microsoft Office – PC, Word, Excel, PowerPoint

 

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®, 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh