Job Description

Expected Travel: None

Requisition ID: 7921

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. To implement strategic Research & Development activities for R&D Kamunting and provide leadership to group leads, project managers, engineers, lab technicians, design and support functions.
2. Lead, oversee and manage all aspects of the design, prototyping, testing (verification and validation) the redesigning and improving existing components, and continually searching for improved quality and cost efficiency.
3. Lead project team members to meet project objectives, and target dates. Establish roles and responsibilities to manage deliverables to meet business commitments.
4. Communicate effectively with key stakeholders on a regular basis to ensure alignment on project baseline (scope, schedule, and budget). Collaborate with project managers on execution of project deliverables and mitigation of risks.
5. Interface with the Marketing Leaders, Product Managers, Sales Partners, Clinicians, and cross functional teams to establish 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 and impacts to development time and cost.
7. Maintains consistent engineering practices, standards, documentation procedures, including design history file and act as a subject matter expert with regards to the relevant product portfolio. Identify technical training and development plans. Maintain leadership and technical capabilities through continued education or training.
8. Lead the team in interpreting complex technical requirements, managing associated risks throughout the development cycle, completing technical studies and design reviews. Ensure compliance to all SOPs, FDA, CE and industry guidelines.
9. Support regulatory submissions and clinical trials as required.
10. Review and conduct assessment of process, design verification and validation including approval when required.
11. Develops staffing requirements and works closely with HR on hiring, personal development plan and utilize appropriate performance management process to drive individual and team performance.
12. Adhere to and ensure the compliance of all Company policies, rules, procedures ad housekeeping standards.
13. 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 :
Honors Degree in an Engineering or Science discipline.
Project Management qualification would be a distinct advantage

Experience
i) 10+ years relevant industry experience preferably Medial Devices
ii) 3+ years management responsibility of research & development or new technology development group

Specialized Skills / Other Requirements

Specialized skills/ technical knowledge:
a) 5 years in Technical position (product/process design) in Medical Industries
b) Strong skills in project and people management:

• Good working knowledge of polymer materials including surface modifications and coating technologies.
• 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.
• Previous experience in new technology and product strategy development and execution of research and development projects
• Ability to delegate tasks and decisions ad set the expectations of responsibility and accountability.
• Understanding and ability to adhere to established quality standards and regulatory compliance and Design Control requirements for medical device industry.
• Strong analytical and problem -solving skills.

c) Effective written and verbal communication skills in English.

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\xc2\xae, Deknatel\xc2\xae, Hudson RCI\xc2\xae, LMA\xc2\xae, Pilling\xc2\xae, R\xc3\xbcsch\xc2\xae, UroLift\xc2\xae and Weck\xc2\xae - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R\xc3\xbcsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

\xc2\xa9 2021 Teleflex Incorporated. All rights reserved.

Teleflex