Catheters Engineer III – Medical Device Development

About the role

Nextern Costa Rica is looking for a highly motivated Catheters Engineer III to lead the design, development, and manufacturing of catheter‑based medical devices. The role spans the full product lifecycle, from concept through commercialization, and requires hands‑on prototyping, design control, and manufacturing expertise.

Key responsibilities

• Lead design and development of catheter devices and delivery systems.
• Drive sustaining activities, improvements, and root‑cause investigations.
• Build, refine, and troubleshoot prototypes in a bench‑development environment.
• Validate processes, create manufacturing procedures, and support scale‑up.
• Collaborate with Operations, Tooling, Quality, and Manufacturing Engineering to ensure robust, scalable processes.
• Maintain Design History File (DHF) documentation, including design inputs/outputs, risk management files, protocols, and change records.
• Participate in design reviews, technical discussions, and project planning to meet program milestones.
• Mentor junior engineers and provide technical guidance.

Required profile

• Bachelor’s or master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• Minimum 5 years of catheter product development experience (7 + years preferred).
• Proven ability to work independently and cross‑functionally in a fast‑paced medical‑device environment.

Required skills

• Catheter design and materials knowledge (nitinol, polymer shafts, braids, coils, adhesives).
• Prototype development and mechanical testing.
• Design control and Design History File (DHF) management.
• Process validation and manufacturing procedure creation.
• Design for Manufacturability (DFM) for braiding, bonding, thermoforming, laser processing.
• Risk management and CAPA activities.