Job Description

Expected Travel: NoneRequisition ID: 10083About Teleflex IncorporatedTeleflex 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 SummaryPrincipal Responsibilities1. Responsible for Design Control document development and execution of Design Verification, Design Validation & Process Validation.
2. Responsible for Test Method Development & Test Method Validation.
3. Responsible for Solidworks drafting for all the AEM products.
4. Develop, execute & document comprehensive test plans and strategies, and develop & build test cases based on the product requirements and usability.
5. Gathers data on current products and involve in improvement of product related documents to support production, engineering, and regulatory requests.
6. Lead multiple projects and make sure they are completed in a timely manner.
7. Understand and assist other team members in updating and maintaining risk documentation to conform to current standards.
8. Serve as a participant in integration core teams as the R&D representative and/or technical lead. Collaborate with the integration teams (Engineering, Quality, Regulatory) to understand technical targets and design control systems
9. Supports sustaining engineering efforts for the Manufacturing plants as applicable. Teleflex is a Global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia, India and Germany. Ability to travel in international locations in mandatory.
10. Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
11. Implementation of new non-hazardous material into manufacturing post MDR certification (Design/ Manufacturing Transfer).
12. And any other assignment / task as deemed fit.Education / Experience RequirementsQualification :
Must have an undergraduate degree in a related engineering/material science field, graduate or advanced degrees strongly preferred.Experience :

• 2 years of medical device or other related design experience.
• Experience in SolidWorks CADD (design/drafting) program.
• Microsoft Office Suite, (Project, Word, Excel and Access).
• Background in Material Science preferred. Injection molding, plastic extrusion and plastic part assembly process and methods preferred.
• U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred.
• ISO and ASTM testing methods for medical devices and general plastic components preferred.
• Principles and practices of professional engineering.
• Regulations pertaining to medical device design and design modifications preferred.
• Demonstrate creativity and ingenuity in applying engineering principles and practices.
• Draw solutions form a wider range of experience.
• Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
• Conduct comprehensive studies and preparation of reports including recommendations.
• Prepare clear and concise statements and reports.
• Establish and maintain cooperative relations with those contracted in the workplace.
• Speak and write English fluently.

Specialized Skills / Other RequirementsNote: 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 employerTeleflex 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.

Teleflex