Job Description

Expected Travel: Up to 10%

Requisition ID: 8394

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

As part of the Anesthesia & Emergency Medicine Business Unit and in the Research & Development team, under minimal direction, the Senior R&D Engineer in our Malaysia Kulim site is responsible for the development of medical devices used in the Airway product portfolio. Experience should focus on research and development project work within Medical Devices. The incumbent in this position leads multiple projects and ensures development phases are completed in a timely manner. The projects span all phases of development, including creation of new designs, creative iterations and enhancements for existing products, and design modifications to meet clinical user needs.

The candidate must be capable of an advanced level scope of projects within the medical device design and development field.

Principal Responsibilities

• Lead R&D new product development projects from concept to commercialization (C2C).
• Partners with marketing and coordinates cross-functionally with clinical, sales, regulatory, operations and shared services teams to define and refine user needs, design inputs and outputs, design transfer and commercialization deliverables.
• Develops total and addressable product market knowledge through collaboration with marketing, clinical, competitor breakdowns, literature reviews and intellectual property research. Leads/attends on-site visits to clinical settings to observe products in clinical use. Coordinate ethnography or task analysis studies to identify unmet needs.
• With an Entrepreneurial mindset, develops and collaborates on concepts, prototypes, and corresponding test methods for rapid development cycles.
• Accountable/responsible for creation of project and product DHF/DMR documentation including but not limited to, Project Charters or Plans, Business Documents and Design Control and D&D Plans.
• Develops and/or coordinates the V&V plans and activities for new and existing products.
• Partners with manufacturing engineering and SMEs for advanced process development and successful design transfer activities.
• Works with the team to problem solve complex technical issues that clear obstacles to ensure successful project delivery.
• Works across global R&D development teams for SMEs and additional resource support by project/phase. Works closely with the Malaysia Kamunting facility engineering team to lead or support Airway development projects manufactured in the site.
• Creates partnerships across global Teleflex engineering and project team networks.
• Develops and implements best practices for project execution within the R&D projects, including but not limited to user needs refinement, indications/clinical use, early concept feasibility and testing, risk-based schedule building, resource allocation and utilization tracking, project updates, budget tracking. Defines and tracks metrics that characterize a successful product launch.
• Maintains timely project plan data in appropriate data systems and reporting dashboards.
• Works with Global Procurement, Operations and external vendors to develop a robust high value product supply chain and to identify opportunities to improve.
• Demonstrates professional responsibilities by collaborating with other personnel to achieve department goals, while Making It Fun.
• Other incidental duties related to AEM R&D department.

Education / Experience Requirements

• A bachelor\'s degree in Mechanical Engineering or related field is required; master\'s degree is preferred.
• 10+ years of professional work experience in the design and development of medical devices.
• Project Management experience required.
• Proficient in SolidWorks advanced tool for product design.
• Proficient in the Microsoft Office Suite, (Project, Word, Excel, and PowerPoint).
• Experience in Injection molding, plastic extrusion and part assembly process/methods will be added advantage.
• Demonstrated success in the product development and launch of medical devices.

Specialized Skills / Other Requirements

• Effectively present information and communicate with all levels including peers, managers, executive leadership, customers, while always Building Trust.
• Strong written and verbal communication skills; excellent attention to detail.
• Solve challenges and deal with a variety of concrete variables in situations where only limited standardization exists. High adaptability, self-motivated and a willingness to try new challenges.
• Analyze complex, technical, and administrative problems and adopt an effective course of action.
• Ability to:

o Form positive relationships which result in better project outcomes and make Teleflex a great place to work.
o Ability to travel domestically and internationally. Up to 15%
o Demonstrate creativity and ingenuity in applying project leadership, engineering principles and practices.
o Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
o Establish and maintain cooperative relationships with those contacted in the course of work.
o Prepare clear and concise updates and reports.
o Speak and write English fluently.

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.

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