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  • 프로젝트명
    Senior / Principal Mechanical Engineer
  • 회사개요
    외국계 의료기기 제조업체
  • 직급
    팀장급(차~부장), 중간관리자급(과장)
  • 경력
    5년 이상 ~ 15년 이하
  • 외국어
    영어3
  • 키워드
    solidworks,AutoCad,MechanicalEngineer
  • 내용
    직무 개요
    - Contribute to the design and development of mechanical components and subsystems for robotic medical devices.
    - Create detailed CAD models and engineering drawings using software such as SolidWorks, AutoCAD, or similar.
    - Develop prototypes and oversee their testing to ensure design feasibility and performance.
    - Collaborate with cross-functional teams including electrical engineers, software engineers, and clinical specialists to integrate mechanical designs with other system components.
    - Conduct rigorous testing and validation of mechanical systems to ensure they meet regulatory and safety standards.
    - Analyze test data and iterate designs based on findings to optimize performance and reliability.
    - Prepare comprehensive technical documentation, including design outputs, tolerance stack analyses, FEA analyses, design specifications, test protocols, and reports.
    - Ensure all designs comply with relevant medical device regulations and standards (e.g., ISO 13485, ISO 14971, FDA).
    - Stay current with advancements in robotics and medical device technology to incorporate cutting-edge solutions into product designs.
    - Identify opportunities for innovation and continuous improvement in existing products and processes.
    - Engage in risk management activities including FMEA and designing and implementing risk controls.
    - Contribute to requirements, prototyping, testing, and assembly efforts for the mechanical components and subsystems.

    경력 요건
    * Required Skills/Abilities
    - 5+ years of mechanical design experience in a regulated industry.
    - Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
    - Strong understanding of mechanical design principles, materials, and manufacturing processes.
    - Experience with FEA (Finite Element Analysis) and other simulation tools.
    - Excellent problem-solving skills and attention to detail.
    - Strong communication and teamwork abilities.
    - Project management skills with the ability to handle multiple projects simultaneously. Preferred Skills/Abilities
    - 10+ years of mechanical design experience in a regulated industry.
    - Strong knowledge of manufacturing processes, equipment, and tooling.
    - Hands-on capability in a lab/production setting and able to function comfortably as an mechanical technician to troubleshoot and assemble product. * Ability to train technicians preferred.
    - Excellent problem-solving skills and ability to troubleshoot and resolve manufacturing issues.
    - Strong attention to detail, organizational skills, and ability to manage multiple tasks and project simultaneously.
    - Familiarity with regulatory requirements and standards (FDA, ISO) for medical devices.
    * Education and Experience
    - Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, Robotics, Aerospace Engineering, or a related field.
    - Minimum 5 years of experience (preferably 10) in the design and manufacturing of regulated products such as medical devices, automotive, or aerospace, with a preference for robotic systems.
    - Proficiency in verbal and written English 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