R&D Project Manager, Tracheostomy

Date: 11 May 2023

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 7968


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. Lead, oversee and manage all aspects of the design, prototyping, testing (verification and validation), risk management and documentation of New Product Development for medical devices, including design control during product life cycle.
2. Lead the redesigning and improving existing components, and continually searching for improved quality and cost efficiency.
3. Lead project team members to meet project objectives, milestones and target dates and establish roles and responsibilities to manage deliverables to meet business commitments. Communicate effectively with key stakeholders on a regular basis to ensure alignment on project baseline (scope, schedule, and budget), report on execution of project deliverables and mitigation of risks. Identify resource constraints and solutions.
4. Lead, conduct and/or participate in design and technical phase reviews and update on project progress as and if required.
5. Interfacing with the Marketing Leaders, Product Managers, Sales Partners, Clinicians, end users and cross functional teams to understand product and market trends, customer preferences/
requirements, and established design criteria for new products and product improvements.
6. Determines the implementation of internal product development processes (e.g. Structured design process) and assesses conformance, impact, and trends in development time and cost. Maintains
consistent engineering practices, standards, and documentation procedures, including design history file and reporting capabilities and act as a subject matter expert with regards to the relevant
product portfolio.
7. Identify and create technical training and development plans with subordinates and monitor progress. Lead the team in interpreting complex technical requirements, managing associated risks
throughout the development cycle, and completing technical studies and design reviews. Maintain leadership and technical capabilities through continued education or training.
8. Interface with suppliers and the strategic sourcing group to obtain quotations, purchase components, and debug problems with production parts. Interface with purchasing and marketing to develop
supply agreements to components and/or new products.
9. Interface with process, development engineers, lab technicians to design and develop new fixtures, tooling and machinery. Assist in the development and qualifications of required manufacturing
10. Ensure smooth transition of new designs from development to production with the Project Leaders.
11. As needed, support, investigation of product complaints to determine root cause and implement corrective action.
12. Support regulatory submissions and clinical trials as required.
13. Review and conduct assessment of process, design verification and validation including approval when required.
14. Adhere to and ensure the compliance of all Company policies, rules, procedures ad housekeeping standards.
15. To ensure implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and
other legislative requirements.

Education / Experience Requirements

Qualification :
BSc in Mechanical, Biomedical, or Plastics engineering desired.

a) 3 years in Medical Devices industries.
b) 1+ year managerial function experience. Leadership skills to effectively coach, mentor and manage a technical group with broad responsibilities.
c) 5 years in Technical position (product/process design) in Medical Industries
d) Strong skills in project planning and people management:
     - Provide frequent feedback and be accountable for their success.
     - Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.
     - Develop a team that has advanced understanding of external and internal customers to effectively to improve design and quality products.
     - Ability to delegate tasks and decisions ad set the expectations of responsibility and accountability.
     - Demonstrated ability to assess and in new technologies and in creating linkage between product/system design, manufacturing, and business results.
     - Understanding and ability to adhere to established quality standards and regulatory compliance and Design Control requirements for medical device industry.
e) Strong analytical and problem –solving skills.
f)  Effective written and verbal communication skills.
g)  Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented within the team

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.