Project Design Engineer

• 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.

• 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).

• 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.

Teleflex