Product Development Engineer

Expected Travel
:
None

Requisition : 453

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

OEM — Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry‑changing innovations and next‑generation solutions for extrusions;

diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Engineer will develop new products while interfacing with customers, vendors, and internal departments to achieve the desired product specifications. The goal is to develop products, define specifications, and establish reasonable time lines while developing high quality products that meet the end users’ expectations. Success in this position relies heavily on meeting dates and maintaining accountability while using experience and judgment to develop products and meet goals with minimal supervision.

• Plan and manage medical device product development efforts including customer interaction, specification and design input documentation, product design requirements, manufacturing process development, risk analysis, design control and process and design documentation.
• Create appropriate documentation required to validate the manufacturing process of a new product under TFX Design Controls Operational Procedures and ISO 13485 Quality System Requirements. Documents required but not limited to:
  Process Validation Protocols/Reports, Risk Assessment Protocols/Reports including PFMEA’s. This will also require the ability to create IQ, OQ and PQ’s as the fundamental core of each process validation. Process validations will include but not limited to:
  Thermal Bonding and Catheter Reflow, Injection Molding, Catheter Joining, Thermoforming and Packaging Pouch Sealing
• Participate in overall product development program management system including regular meetings and discussions around project priorities and project status updates.
• Prototype medical devices.
• Train and supervise technicians and assemblers in the manufacture of medical devices.
• Identify new manufacturing or product technologies for review and possible development activities within the product development group.
• Identify and manage vendor relationships to support introduction of new product designs to the market.
• Travel to customers, vendors and alternate manufacturing locations, as needed.
• Apply appropriate quality procedures and product documentation to production builds and monitors each for quality conformance.
• Develop a complete understanding of TFX documentation system as it applies to manufacturing.
• Understand and utilize yield analysis data as a continuous improvement tool.
• Perform other duties as assigned.

This position requires direct contact with an implantable device. ☒ Yes ☐ No

• Bachelors degree in Engineering required. Mechanical, Chemical, Biomedical or related technical field is preferred.
• Individual must have a 2 to 5 years’ experience in…