Project Design Engineer

Expected Travel : Up to 10%

Requisition ID : 12632

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peoples 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, Rusch, 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.

Vascular Access Built on a history of innovation, our Arrow brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients lives.

As a Project Design Engineer, you will play a key role in the design, development, and optimization of vascular access catheters. This is a hands-on, hybrid role that blends CAD-based design with prototyping and testing in our state-of-the-art labs. Youll work closely with cross-functional teams including manufacturing, quality, and regulatory to bring innovative catheter solutions from concept to commercialization using design control processes. You could participate in all technical phases of product development, including concept development, design and development, requirements definition, edge-of-failure testing, verification and validation testing, and design transfer. You will bring fresh design thinking, materials knowledge, and predictive engineering techniques to help elevate our design capabilities.

Design or redesign vascular access catheters and/or related components to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner.
Plan and technically execute design projects from prototype design through testing and into production. Formulate decisions to facilitate project advancement.
Create and iterate on Solidworks 3D models, 2D drawings, simulation models, statistical design transfer functions, and design documentation.
Build and test prototypes in the lab using a variety of fabrication techniques (e.g., extrusion, molding, bonding, machining, 3D printing).
Participate in risk analysis (FMEA), design reviews, and root cause investigations.
Conduct design verification and validation activities, including bench testing, simulated use, and clinical feedback integration.
Collaborate with process development engineers, manufacturing, and lab technicians to design and develop new fixtures, tooling and machinery. Assist in the development and qualification of required manufacturing processes.
Stay current with emerging materials, catheter technologies, and design methodologiesand share this knowledge with the team.
Support regulatory submissions with design documentation and technical justifications.
Interface with clinicians, marketing, and process development to understand customer preferences and establish design criteria for new products and product improvements.
Interface with vendors and purchasing to obtain quotations, purchase components, and debug problems with production parts.
Investigate product complaints or test failures to determine root cause and implement corrective actions.
Represent the engineering department at hospitals, scientific sessions, and seminars to meet with medical personnel and discuss product line requirements and trends.
Document all new ideas for products and/or processes to drive new intellectual property.
Assist process development and manufacturing personnel with the transfer of development projects and design changes in production.
Ensure projects are developed and documented in compliance with the Quality System and with FDA and ISO standards.
Comply with Teleflex's Code of Ethics, all company policies, rules, procedures and housekeeping standards.

Bachelor of Science Engineering or equivalent technical discipline
Preferred: Master of Science Engineering or equivalent technical discipline
Minimum of 3 years of previous experience in related field (e.g. medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).

Self-motivated, high-energy, positive attitude individual with the initiative and drive for timely completion of
goals. Able to travel domestically and internationally.

Technical Knowledge:
Basic understanding of mechanical systems, fluid dynamics, and material properties related to vascular access devices.
Awareness of Design for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design.
Understanding of verification and validation principles, including ISO 14971 risk management.
Ability to perform basic statistical analyses using Minitab or equivalent software.

Regulatory and Compliance:
Familiarity with design control processes, regulatory requirements (e.g., ISO 13485 and FDA 21 CFR 820) and quality standards for medical devices.
Understanding of design verification and validation, risk management, and usability engineering principles.
Awareness of change control processes, including ECOs (Engineering Change Orders) and CAPA procedures.

Process Development and Manufacturing Support:
Basic knowledge of process validation, including IQ, OQ, and PQ requirements.
Exposure to PFMEA and risk assessment tools related to manufacturing and design transfer.
Understanding of material variability and manufacturing process adjustments to improve consistency and efficiency.

Project Management and Collaboration:
Strong documentation skills, including writing test reports, design justifications, and regulatory submissions.
Ability to work in cross-functional teams, collaborating with R&D, quality, regulatory, manufacturing, and clinical teams.
Effective communication skills to present technical information clearly and collaborate with internal and external stakeholders.
Strong analytical and problem-solving skills.
Effective verbal and written communication skills. Team player with good interpersonal skills.
Proficient in Microsoft Office Suite and computerized design and analysis applications.
Prior experience with polymer component design and catheter design for vascular access or interventional devices is highly desirable.

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TRAVEL REQUIRED: 10 %

WORKING ENVIRONMENT:
Office/Professional Plant/Manufacturing Remote/Field Laboratory

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 Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: ... or ....

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rusch, 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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