Catheters Engineer III
On-siteCartago, Cartago Province, Costa Rica
Job Summary
Catheters Engineer III at Nextern Costa Rica leads and participates in design and development of catheter-based medical devices and delivery systems, sustaining improvements, and translating product requirements into functional engineering solutions. Responsibilities include hands-on bench development, prototype troubleshooting, process validation, collaboration with Operations, Quality, Tooling, and Manufacturing Engineering, supporting DFM initiatives for catheter assembly and related processes, maintaining DHF documentation, participating in design reviews and project planning, and mentoring junior engineers. Requires deep knowledge of catheter design, materials, manufacturing processes, design controls, risk management, and ISO/IEC/ CFR standards, with strong communication and problem-solving skills.
Required Qualifications
- 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
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