MDR R&D Engineer (Contract)

Date: 26-Feb-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3316

 

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.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Principal Responsibilities

1.    Update/ establish UOUP, Trace matrix, UFMEA, update DHF documentation, where required
2.    Provide support and input to the design related section of MDR Technical Documentation Summary (e.g. Device Design History, Device Design, etc).
3.    Responsible to plan, coordinate and execute ISO Compliance/ design verification activities and related qualification (i.e machine, test method, etc) and product equivalent standard to meet MDR state of the art. 
4.    Management of the project activities to complete within the predetermined MDR timeline.
5.    Responsible to execute investigation of ISO compliance/ design verification studies/ stability study not meeting specification and troubleshoot the issues in systematic and statistical manner, for root cause due to design.
6.    Provide input related to the shelf life study performance of the product
7.    Support Iabels/ IFUs update on technical data for MDR update. 
8.    Support HA & PFMEA Update activities.
9.    Execution of Chlorhexidine removal study.
10.  Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation and qualification is available, adequate records are produced, and adequate to meet Quality System and Regulatory requirement. 
 

Education / Experience Requirements

Qualification:
Bachelor degree in Engineering/Science or equivalent

Experience:
Minimum 1 year in R&D related experience, preferable in medical device industry
 

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

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.