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.
Requirements
- Bachelor’s or master’s degree in biomedical engineering, Mechanical Engineering, or related engineering discipline
- Minimum of 5 years of medical device catheter product development experience; 7+ years preferred
- Strong experience in the development and manufacturing of complex catheter systems
- Strong understanding of catheter materials including hypo tubes, nitinol, polymer shafts, braids, coils, adhesives, and bonding processes.
- Demonstrated hands-on experience building prototypes, performing mechanical testing, and interpreting performance data
- Experience identifying and supporting appropriate catheter manufacturing processes and assembly methods.
- Strong experience in the Test method validation, manufacturing procedures creation and process validation
- Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820
- Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO 25539, and related standards
- Strong analytical, problem-solving, and troubleshooting skills
- Effective verbal and written technical communication skills
Benefits
Competitive compensation package
Skills Required
- Bachelor's or master's degree in Biomedical, Mechanical, or related engineering discipline
- Minimum of 5 years of medical device catheter product development experience
- 7+ years catheter product development experience (preferred)
- Strong experience in development and manufacturing of complex catheter systems
- Deep understanding of catheter materials (hypo tubes, nitinol, polymer shafts, braids, coils) and adhesives/bonding processes
- Hands-on experience building prototypes, performing mechanical testing, and interpreting performance data
- Experience identifying and supporting catheter manufacturing processes and assembly methods (braiding, bonding, thermoforming, laser processing)
- Strong experience in test method validation, creation of manufacturing procedures, and process validation
- Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820
- Familiarity with applicable medical device standards (ISO 10555, ISO 11070, ISO 5840, ISO 25539)
- Strong analytical, problem-solving, and troubleshooting skills
- Effective verbal and written technical communication skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
