Teleflex

Project Design Engineer

Teleflex

full-time

Posted on:

Origin:  • 🇺🇸 United States • Pennsylvania

Visit company website
✨ AI Apply
Apply

Job Level

Mid-LevelSenior

About the role

  • 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. You’ll 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. Principal Responsibilities
  • 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 methodologies—and 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.

Requirements

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.