R&D Assistant Manager - Project Support

Date: 14 Jun 2024

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 10224

 

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.    Guide, direct & coordinate between the Development Engineers and project team on related R&D Projects.
2.    Initialize & monitor personnel training program for R&D Engineers with primary focus on Engineer’s exposure to clinical procedures and help establish / maintain effective communication links and networking with established medical institutions.
3.    Provide leadership in the review, update & training with regard to the maintenance of the Design Control Procedures.
4.    Functions in a proactive role in research or development activities in the advance level scope of assignments, including studies & projects requiring analysis, extensive research associated with new design & design modification of medical devices, components and/or formulations.
5.    Functions also in other qualified capacities as a primary engineering resource on material, special project, process improvements and six sigma initiatives when required.
6.    Serves as project leader or guides the Development Engineers for the development of the project plan with critical milestones & timeline and with the responsibility to follow up on all aspects of projects including review with support groups and outside resources where applicable.
7.    Develops & coordinates the running protocol for the validation of new or modified devices or components including validations of designs, manufacturing, assembly, packaging and sterilization where applicable with Development Engineers and the appropriate support group departments such as engineering, regulatory, documentation, tooling and manufacturing. 
8.    Interface with process engineering & quality engineering to coordinate changes in process, tooling, equipment and material identified to positively impact the manufacturing process while staying within the regulatory requirements and Product Design Control procedures. 
9.    Perform technical assessments of audit and project files with certification decision based on requirements from ISO 13485, ISO 9001, MDSAP, AIMDD/MDD/IVDD, MDR. 
10.    Answer internal and external requests regarding regulatory requirements.
11.    Communicate in a prompt, courteous and effective manner with internal and external customers in all circumstances including providing information, answering questions, and relaying messages.
12.    Responsible to serve as team member for packaging assurance support & CAPA standards. 
13.    Other tasks as needed.
 

Education / Experience Requirements

Qualification    :    
Degree in a related engineering/polymer engineering/material science field, graduate or advanced degrees strongly preferred.

Experience    
a)    5-7 years proven development experience, ideally with 5 years in the Medical device industry and proven track record in innovative product design, development and implementation. Experience in regulating environment preferred.
b)    Strong skills in project planning and people management:
-    Actively develop a mentor associate. Provide frequent feedback and be accountable for their success.
-    Build a team with world-class expertise in product development
-    Develop a product development organization that has advanced understanding of external and internal customers to effectively to improve design and quality products.  
c)    Must have strong organizational leadership, interpersonal and influencing skills. 
d)    Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction. Confident to work with different levels of professionals and flexible approaches to problems.
e)    Integrity and trust - unwavering commitment to "doing the right thing" 

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.