Senior R&D Engineer

Date: 09-Nov-2021

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 5041

 

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 R&D Project Manager is responsible for the development and launch of medical devices used in the Airway and Emergency Medicine product portfolios. Experience should focus on research and development projects work within Medical Devices. The incumbent in this position leads multiple projects and ensures development and commercialization 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 modifications to product designs. The candidate must be capable of an advanced level scope of projects within the medical device design and development field.  

Under minimal direction, the Senior Project Engineer is responsible for the sustaining engineering projects of Anesthesia and Emergency medicine products.  Assignments may include work for other products within the Teleflex portfolio. Experience and background requirements should focus on disposable medical device products. 
This position generally has PTG (Product Technology Group) responsibility, including organizing and managing multiple projects and insuring they are completed in a timely manner.  Assignments will primarily focus on sustaining engineering assignments providing creative solutions to existing products when problems arise, or modifications are requested. 

The candidate must be capable of advanced level scope of assignments in planning, designing and coordinating the development and implementation of related engineering activities to support changes and improvements to existing products lines projects through manufacturing scale-up. Incumbent at this level receive only occasional instruction or assistance as new or unusual situations arise and are fully aware of the operating procedures and policies of the work unit
 

Principal Responsibilities

•    R&D Project Manager for Sustaining and Line extension projects.
•    Serve as design control lead for new product development projects when required.
•    Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables. 
•    Coordinates the development of 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, CAPA’s & R&D Investigations, Business Documents, Design Control and D&D Plans.  
•    Develops and/or coordinates the V&V plans and activities for new and existing products.
•    Works with the team to problem solve complex technical issues that clear obstacles to ensure successful project delivery.
•    Works across R&D development teams for SMEs and additional resource support by project/phase.
•    Creates partnerships across global Teleflex PMO, engineering, and project team networks.
•    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.
•    Develops assembly methods and procedures; creates engineering drawings and specifications. 
•    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.
•    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. 
•    Demonstrates professional responsibility by collaborating with other personnel to achieve department goals while fostering an enjoyable environment. 
•    Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams
•    Prepares formal documentation of the product designs, risk analysis, product specifications, etc. according to established product development procedures.   
•    Initiates formal reviews to get approved per said procedures.
•    Investigates and resolves technical production problems involving product performance.  

Education / Experience Requirements

•    A bachelor’s degree is required; degreed technical field or master’s degree is preferred.
•    6+ years of professional work experience in the project management, engineering for the development of medical devices.
•    Project Management experience required.
•    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

•    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    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®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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