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  • 프로젝트명
    Design Engineer II - Instruments
  • 회사개요
    외국계 의료기기 제조업체
  • 직급
    중간관리자급(과장), 실무자급(대리이하)
  • 경력
    3년 이상 ~ 8년 이하
  • 외국어
    영어3영어3
  • 키워드
    IEEE/IEC 62304,Design_engineer,3D_Modeling,Mechanical_Design,Machine_Design
  • 내용
    직무 개요
    - Assist in the research, design, and development of apparatuses and equipment for testing and prototyping.
    - Follow GDP (Good Documentation Practices) for design history including design review, protocols, reports, and drawings.
    - Gather clinical inputs then implement in the design output.
    - Lead root cause analysis and provide solutions in a fast-paced environment.
    - Design and conduct mechanical testing.
    - Interpret and report mechanical testing findings for verification and validation.
    - Work as part of a team of Design Engineering staff to bring designs through prototyping and into serial production.
    - Maintain positive and collaborative relationships with vendors and suppliers.
    - Hands-on fabrication and assembly for prototyping required.

    경력 요건
    * Required Skills/Abilities
    - Advanced 3D modeling.
    - Knowledge of design for manufacturability.
    - Mechanical Design, Machine Design, or equivalent.
    * Preferred Skills/Abilities
    - Experience in 3D modeling of electro-mechanical systems.
    - Finite element analysis and complex tolerance analysis.
    - Rapid prototyping.
    - Capital and Disposable medical device design.
    - Machining experience.
    - Robotics/kinematics knowledge.
    - Experience engaging with physician customers to discuss and evaluate design concepts to drive innovation.
    - Experience in the development and commercialization of a medical device products.
    - Ability to review and critically assess patents and other forms of intellectual property.
    - Experience with IEEE/IEC 62304, IEC 60601.
    - Familiarity with FDA GMP/ISO 13485, 14971 standards for medical devices.
    - Familiarity with 21 CFR 820.
    - Familiarity with testing standards such as ASTM.
    * Education and Experience
    - Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
    - Minimum of 3 years of design engineering experience.

    처우
    - Negotiable

    제출 기한
    - ASAP

    제출 서류 및 기타
    - 국/영문 이력서 및 자기소개서

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