Sr. Process Development Catheter Engineer

Nextern Costa Rica is seeking a highly motivated Process Development Catheter Engineer with strong experience in the design, development and manufacturing of catheter medical devices. This role is intended for candidates who are comfortable working hands-on, driving technical development activities, sustaining activities and contributing throughout the full product lifecycle from concept through commercialization. The ideal candidate will possess deep technical knowledge of catheter design, materials, and manufacturing processes, along with the ability to collaborate cross-functionally within a fast-paced medical device development environment. This position requires a strong balance of engineering fundamentals, hands-on prototyping capability, design control knowledge, and practical manufacturing understanding.

DUTIES AND RESPONSIBILITIES: • Participate in and/or lead the design and development of catheter-based medical devices and delivery systems. • Participate in and/or lead the sustaining support/improvements for catheter-based medical devices and delivery systems. • Develop innovative design concepts and translate product requirements into functional engineering solutions. • Build, refine, and troubleshoot prototype devices through hands-on bench development. • Process validation activities related to catheter medical devices.  • Collaborate with Operations, Tooling, Quality, and Manufacturing Engineering teams to develop robust and scalable manufacturing processes. • Support Design for Manufacturability (DFM) initiatives related to catheter assembly, braiding, bonding, thermoforming, laser processing, and other specialized manufacturing techniques. • Prepare and maintain Design History File (DHF) documentation including design inputs, design outputs, risk management files, protocols, reports, and engineering change documentation. • Participate in design reviews, technical discussions, and project planning activities to support program milestones and deliverables • Support root cause investigations, CAPA activities, and product/process improvement initiatives. • Mentor junior engineers and provide technical guidance where applicable. • Perform other duties as assigned in support of engineering and business objectives.