◈ 직무 개요

- Lead the technical development of steerable overtube device, ensuring the successful execution of design, verification and validation (V&V) activities.
- Lead the research, design and development of apparatuses and equipment for testing and prototyping.
- Support the development of V&V test protocol, report, test fixtures and equipment.
- Support the regulatory submission documentation preparation (De Novo & 510 (k)), ensuring successful approval.
- Ensure compliance with Good Documentation Practices (GDP) throughout the entire product development process, including design reviews, protocols, reports, drawings, specifications and BOM.
- Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical and Marketing) to ensure alignment of project timelines, deliverables and objectives.
- Incorporate clinical and marketing feedback into design outputs to align with customer needs and regulatory requirements.
- Prepare the product for commercialization by ensuring successful transition from development to manufacturing including supporting regulatory submissions and product launch activities.
- Hands-on fabrication, assembly, and troubleshooting of prototypes required as part of product development process
- Provide technical leadership and mentorship to junior engineers and other team members.
- Foster positive, collaborative relationships with vendors and suppliers to ensure timely project delivery.

◈ 경력 요건

- Proficiency in CAD software. Solidworks (and its simulation tools) highly preferred.
- Extensive experience in designing electro-mechanical systems.
- Expertise in FEA, GD&T and tolerance stack-up analysis
- Familiarity with V&V processes to ensure compliance with FDA.
- Strong knowledge of DFM, especially for injection molding and machining
- Ability to conduct root cause analysis and implement solutions in a fast-paced environment.
- Ability to conduct engineering studies, interpret results and incorporate them in design.
- Ability to write and review V&V test protocols and reports.
- Experience in the complete product development lifecycle and commercialization of medical device products from concept design through prototyping, V&V, regulatory submission and approval (IDE, De Novo, 510(k)), ensuring compliance with applicable regulatory standards at every stage.
- Strong communication skills, both written and verbal, for effective collaboration with internal teams and vendors.
- Hands-on experience in prototyping, assembly and troubleshooting.
* Preferred Skills/Abilities

- Knowledge of robotics, particularly in the context of surgical or medical devices.
- Knowledge of complex flexible tubing and catheter design. (extrusion, lamination, coating, low friction liner, laser cut hypotube, coil and braid)
- 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).
- Ability to review and critically assess patents and other forms of intellectual property.
- Experience with risk management processes (DFMEA)
- Proficiency in written and verbal communication in English is preferred.
* Education and Experience

- Bachelor’s degree in mechanical engineering, biomedical engineering, or related Engineering discipline.
- M.S. or Ph.D. preferred.
- Minimum of 8 years of engineering experience within the medical device industry, with specific experience in robotic systems strongly preferred.

◈ 처우

- Negotiable

◈ 제출 기한

- ASAP

◈ 제출 서류 및 기타

- 국/영문 이력서 및 자기소개서

◈ 담당 컨설턴트

- 이건교 / 02-2016-6602 / at6gule1@vpeople.co.kr