Job Description

Expected Travel: NoneRequisition ID: 10789About Teleflex IncorporatedAs 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, QuikClot, LMA, Pilling, R\xc3\xbcsch, 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 SummaryThe candidate will participate in cross functional reviews of the Technical Files to ensure all test requirements are being planned and executed in a timely manner.

• Plan and coordinate activities of technical resources assigned to updating Tech Files and Design Dossiers in preparation for new regulations.
• Coordinate overall planning and resource allocation and activities to meet target dates as defined by the BU regulatory lead
• Generate test protocols, analyze test data, and generate written reports.
• Contribute to design documentation including input for the DHF and technical design reviews.
• For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
• Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as DOE, accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
• Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
• Interface with suppliers to obtain information required to update Tech Files and DHF documentation. Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
• Direct the efforts of technicians and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
• Lead and participate in design and technical phase reviews.
• Ensure projects are developed and documented compliant with the Quality System.
• Perform any other relevant and related responsibilities that may be assigned from time to time as required by superior.

Principal ResponsibilitiesEducation / Experience Requirements

• Degree in Industrial/Mechanical Engineering or equivalent.
• Knowledge of PVC and/or Silicone Processing and process development will be an added advantage.
• 2-3 years previous experience in related field (e.g. medical device R&D, manufacturing and assembly, disposables manufacturing processes, plastics, silicone)

Specialized Skills / Other Requirements

• Must be able to communicate (written and verbal) in English and Malay language.
• Strong project management, documentation and problem-solving skills.
• Good knowledge in Engineering Testing, Jig and Fixture, etc.
• Good interpersonal skills that include working well in a team environment and the ability to lead others.
• Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
• Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
• Knowledge of Solidworks or equivalent CAD software is a Plus.
• Computer Literate (MS. Excel, Word, PowerPoint, etc).

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, QuikClot, 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 2024 Teleflex Incorporated. All rights reserved.

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