R&D Engineer at Teleflex Medical - Italy

Kamunting, Perak, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

0.0

Posted On

28 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Engineering, Medical Devices, Design Control, Injection Molding, Plastic Extrusion, FDA GMP, ISO Requirements, Risk Analysis, Validation, Prototyping, Cross-Functional Coordination, Technical Problem Solving, Documentation, Assembly Methods, Collaboration

Industry

Medical Equipment Manufacturing

Description

Expected Travel: None Requisition ID: 12889 About Teleflex Incorporated 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 Principal Responsibilities 1. R&D Engineer for Sustaining and Line extension projects.2. Serve as design control lead for new product development projects when required.3. 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.4. Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles.5. Accountable/responsible for creation of project and product DHF/DMR documentation including but not limited to Project Charters or Plans, CAPA’s & R&D Investigations, Business Documents, Design Control and D&D Plans.6. Develops and/or coordinates the V&V plans and activities for new and existing products.7. Works with the team to problem solve complex technical issues that clear obstacles to ensure successful project delivery.8. Works across R&D development teams for SMEs and additional resource support by project/phase.9. Creates partnerships across global Teleflex, engineering, and project team networks.10. 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.11. Develops assembly methods and procedures; creates engineering drawings and specifications.12. 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.13. 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.14. Demonstrates professional responsibility by collaborating with other personnel to achieve department goals while fostering an enjoyable environment.15. Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.16. Prepares formal documentation of the product designs, risk analysis, product specifications, etc. according to established product development procedures.17. Initiates formal reviews to get approved per said procedures.18. Investigates and resolves technical production problems involving product performance.19. Performs other related duties as assigned or requested.Education / Experience Requirements Qualification : Bachelor’s degree is required; degreed technical field or master’s degree is preferred. Experience : • 5 years of professional work experience in the project management, engineering for the development of medical devices.• Project Management experience preferred.• Proficiency in the Microsoft Office Suite, (Project, Word, Excel, and Access) is required.• Injection molding, plastic extrusion and plastic part assembly process and methods• U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices• Design Control experience: technical mindset to develop skillset required.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. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2025 Teleflex Incorporated. All rights reserved.

Responsibilities

The R&D Engineer will lead sustaining and line extension projects, coordinating cross-functionally to define user needs and design inputs. They will also be responsible for developing concepts, prototypes, and validation plans for new and existing products.