R&D Staff Engineer

Date: 26 Sep 2023

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 8892


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

The Staff Engineer will Lead & Co-ordinate key NPI & Sustaining projects.  Provide technical direction and support to R&D Teams across various facilities.  They will be an expert in R&D processes (Design Control, Statistical Analysis,etc) with a broad base of experience in technologies, designs, materials and engineering principles.  Tracheostomy experience in preferred for the role.

Principal Responsibilities

•    Engineering lead for Sustaining, NPI and research, activities to implement new or redesigned products, processes, components, and formulations.   Identify and create new design and/or process concepts.  
•    Function as primary engineering resource on materials, special projects and project improvements as required.
•    Serve as project leader or guides the development engineers for the project plan with critical milestones & timeline and with the responsibility to follow up on all aspects of projects including reviews with the support groups and outside resources where applicable.
•    Interface with clinicians, marketing, and process development to understand customer preferences/requirements and establish necessary design criteria for new products and product improvements
•    Develops & coordinates the running of protocol for the validation of new, modified devices or components including validations of design, manufacturing, assembly, packaging and sterilization &  where applicable support group departments such as engineering, regulatory, documentation, tooling & manufacturing.
•    Lead, conduct and/or participate in design and technical phase reviews
•    Interface with purchasing, vendors and marketing to develop new components/products/technologies by providing technical requirements and assisting with supply agreements 
•    Update and review project progress on an as required basis by manager
•    Interface with process development engineers, manufacturing and lab technicians to design and develop new fixtures, tooling, and machinery.  Assist in the development and qualifications of required manufacturing processes.
•    Develop new products and product concepts using existing and emerging technologies per Design Control requirements and Concept to Commercial (C2C).
•    Contribute to our culture that thrives on core values, with people at the center of all we do. Working together, our shared values of Entrepreneurial Spirit, Building Trust, and Make It Fun allow us to produce outstanding products and services that genuinely make a difference to people's lives around the world.
•    Serve as a mentor for engineering personnel on clinician interaction, product design development, verification/validation testing, documentation, and manufacturing related processes
•    Represent the engineering department at hospitals, scientific sessions, and seminars to meet medical personnel and discuss product line requirements and trends
•    Document all new ideas for products and/or processes as Company's intellectual property. Work with Patent Attorney’ s to file new patents and assess infringement potentials.
•    Assist process development and manufacturing personnel with the transfer of development projects and design changes into production
•    Support regulatory submissions and clinical trials as required
•    And any other assignment / task as deemed fit.

Education / Experience Requirements

Typically requires a minimum of 7 years of related experience with a Bachelor’s degree in Mechanical 
       Engineering, Polymer Engineering or other related engineering fields
•    Preferably with minimum 7 years working experience in medical devices and R&D environment
•    Strong Preference for min 7 years in Medical Device.
•    Knowledge and experience with Tracheostomy a strong advantage
•    Strong analytical and problem-solving skills.
•    Effective verbal and written communication skills.
•    Team player with good interpersonal skills.
•    Proficient in Microsoft Office Suite and computerized analysis applications
•    Proficient in tool design, stack up of tolerances, Solid works
•    Self-motivated, high energy, positive attitude with initiative and drive for timely completion of goals.  
•    Able to travel domestically and internationally.

Specialized Skills / Other Requirements

•    Exceptional mechanical design skills on complicated mechanisms and systems.
•    Expertise in SolidWorks.
•    Experience in the practical application of statistics and working knowledge of a statistical analysis package 
•    Ability and experienced in approaching challenging and/or ambiguous engineering problems with scientific 
      logic and problem-solving skills. Ability to communicate complex technical concepts clearly and concisely is 
•    Mastery of all phases of product development including design verification, validation, implementation and 
•    Demonstrated history of products successfully reaching the marketplace.
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control, ISO 14971, GMP and other standards as 
      they relate to the development and manufacture of medical device would be an advantage.
•    Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485 and 
      all other international regulatory requirements with which Tracheostomy product complies. 

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.