◈ 직무 개요

- Lead the mechanical design and iterative development of the steerable overtube device, ensuring compliance with design controls, regulatory standards, and documentation practices.
- Design, verification, and validation (V&V) activities, including protocols, reports, and development of custom test fixtures and equipment.
- Develop manufacturing documentation (MPIs, WIs) and support smooth transition from development to pilot builds and commercialization.
- Contribute to regulatory submissions (De Novo & 510(k)) by preparing technical documentation aligned with design outputs.
- Collaborate with cross-functional teams and suppliers, while engaging in prototype fabrication, troubleshooting, and technical problem-solving during development..

◈ 경력 요건

- Proficiency in CAD (SolidWorks highly preferred), with experience in Assembly, 2D drawings, and tolerance analysis.
- Proven expertise in complex flexible tubing and catheter design (extrusion, lamination, coating, liners, laser-cut hypotubes, coil and braid).
- Strong background in mechanical mechanism design, compliant structures, DFM, and hands-on prototyping, assembly, and troubleshooting.
- Familiarity with V&V processes, FDA regulations, and ability to design, execute, and document verification/validation testing.
- Experience conducting engineering studies, root cause analysis, and implementing solutions throughout the full product life cycle, including regulatory submissions (IDE, De Novo, 510(k)) and commercialization.
- Effective communication and collaboration skills for working across cross-functional teams and with external vendors.

Preferred Skills/Abilities
- Knowledge of robotics, particularly in the context of surgical or medical devices.
- Knowledge of biocompatible materials compliant with ISO 10993.
- Familiarity with sterilization validation activities compliant with ISO 11135.
- Familiarity with ISO standards related to medical devices and testing standards such as ASTM and IEC (60601).
- Extensive experience in designing electro-mechanical systems.
- Strong understanding of DFM principles, especially for injection molding and machining
- Experience reviewing and contributing to patient and IP strategy and other forms of intellectual property.
- Experience with risk management tools such as DFMEA and PFMEA.
- Proficiency in written and verbal communication in English.
- Minimum of 8 years of engineering experience. Specific experience in robotic systems/medical device industry.
- Travel up to 15%.
 
Education and Experience
- Bachelor’s degree or advanced in mechanical engineering, biomedical engineering, or related Engineering discipline.
- Minimum of 5 years of engineering experience within the medical device industry. 

◈ 제출 서류 및 기타

- 영문 이력서 및 자기소개서

◈ 담당 컨설턴트

- 이건교 / 02-2016-6602 / [email protected]