R&D Engineer 2

Teleflex; Malaysia; On-site; MYR 120,000 - 180,000; Full time

Job summary

Teleflex Global Operations in Malaysia is seeking a driven engineer to lead validation of materials, packaging and products, ensuring quality and functionality. The role spans market research, concept development, design transfer, and documentation across cross-functional teams.

You will manage DHF/DMR, coordinate project plans, and drive CAPA investigations and regulatory support. Travel domestically and internationally may be required.

Qualifications

• Undergraduate degree in engineering/material science; graduate or advanced degrees preferred.
• Strong analytical and problem-solving skills; capable of documenting designs and testing activities.
• Fluent in English; good communication and teamwork abilities.

Responsibilities

• Develop/validate materials, packaging or finished products to ensure quality and functionality.
• Lead Front End Innovation activities for new product development, including market research and concept development.
• Coordinate cross-functionally to document user needs, design inputs/outputs, transfer and commercialization deliverables.
• Create and maintain DHF/DMR documentation and project charters; manage plans and milestones.
• Lead investigations, CAPAs, regulatory support, and QA-related activities; support for design reviews.

Skills

Engineering background

Medical Technology packaging

Analytical skills

Communication skills

English proficiency

Education

Bachelor's degree in engineering/Materials science

Tools

Microsoft Office

Minitab

Job description

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. 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

• 1. Develop, identify, experiment, conduct and coordinate validation, verification of proposed materials/ packaging or finished products to ensure their quality and functionality
• 2. Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development.
• 3. Own and execute technical deliverables within the project as required.
• 4. Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations (Internal/External) and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables as per the design control procedure.
• 5. Document all new ideas for products and/or processes which should be assessed for intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement
• 6. Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles.
• 7. Accountable/responsible for creation of project and product DHF/DMR documentation.
• 8. Create and update Project Charters, project plan, use of project management template for execution and tracking on a required basis by manager.
• 9. Accountable and responsible for NC’s/CAPA’s & R&D Investigations, Business Documents, Design Control and D&D Plans.
• 10. Support for LANSA, DSD, Labelling, IFU and Quantum related activities.
• 11. Develops and/or coordinates the V&V plans and activities for new and existing products.
• 12. Works with the team to solve complex technical issues that clear obstacles to ensure successful project delivery.
• 13. Works across R&D development teams for SMEs and additional resource support by project/phase.
• 14. Manages product development, compliance and improvement project to meet end user, marketing and regulatory needs.
• 15. Conduct statistical analysis for process stability monitoring & seek opportunity of cycle time and productivity improvement using process capability study (Cpk), Design of Experiment (DOE), Statistical Process Control (SPC) tools etc.
• 16. Works with Global Procurement, Operations, and external vendors to ensure development of a robust high value product supply chain and to identify opportunities to improve.
• 17. Develops assembly methods and procedures; creates engineering drawings and specifications.
• 18. Develops and maintains project plans with detailed schedules and critical milestones, risks, resource loading and budgets. Maintains timely project plan data in appropriate data systems and reporting dashboards.
• 19. Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.
• 20. Demonstrates professional responsibility by collaborating with other personnel to achieve department goals while fostering an enjoyable environment.
• 21. Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
• 22. Support technical file preparation, regulatory submissions and audits as required.
• 23. Prepares formal documentation of the product designs, risk analysis, product specifications, etc. according to established product development procedures.
• 24. Lead and participate in design and technical phase reviews.
• 25. Any other assignment / task as deemed required to meet project deliverables.

Education / Experience Requirements

Qualification: Must have an undergraduate degree in a related engineering/material science field, graduate or advanced degrees strongly preferred.

Experience

• a) Talented and ambitious to learn and get things done
• b) The candidate has an engineering background in Medical Technology, packaging, plastic, or chemical engineering. Ideally some relevant work experience in manufacturing, Quality Assurance, engineering, or Product Development related to Medical Device Industry. Candidates with an engineering background in electronic or mechanical education are preferred.
• c) Relevant work experience (Fresh graduate or till 2 years: P1) and 2-4 years: P2 and P3) in relevant manufacturing Industry will be considered.
• d) Good skills with computers and standard software as well fluid English skills in oral and written are a must.
• e) Strong analytical and problem-solving skills.
• f) Effective verbal and written communication skills.
• g) Team player with good interpersonal skills.
• h) Proficient in Microsoft Office, Minitab and others computerized analysis applications
• i) Self-motivated, high energy, positive attitude with initiative and drive for timely completion of goals.
• j) Able to travel domestically and internationally

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.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.