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  • 프로젝트명
    Senior Engineer - Instruments
  • 회사개요
    외국계 의료기기 제조업체
  • 직급
  • 경력
    8년 이상 ~ 15년 이하
  • 외국어
    영어3
  • 키워드
    Instruments&Accessories,EndoDrive,solidworks,AutoCad,CAD
  • 내용
    직무 개요
    - Lead the development and manufacturing of medical device robotics specifically focusing on instruments, EndoDrive, and accessories.
    - 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.
    - Provide strategic direction and leadership for the team, ensuring the successful execution of projects within budget and timeline constraints.
    - Collaborate with cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure the successful development and implementation of new robotic technologies.
    - 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 specifications, test protocols, and reports.
    - Ensure compliance with all relevant regulatory requirements and standards, including FDA regulations, ISO standards, and Good Manufacturing Practices (GMPs).
    - Identify opportunities for innovation and continuous improvement in existing products and processes.

    경력 요건
    * Required Skills/Abilities
    - 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.
    - Excellent analytical and strategic thinking skills.
    - Strategic thinker with the ability to analyze, understand and effectively communicate deep technical material to all levels of the organization.
    - Must be a detail and goal orientated, self-motivated individual with the ability to multi-task.
    - Ability to travel internationally.
    * Preferred Skills/Abilities
    - Strong understanding of GMP’s, FDA regulations, and ISO standards related to medical device manufacturing.
    - Experience in the development and implementation of robotic technologies for medical devices preferred.
    - Great interpersonal skills and works well across the matrix with cross-functional teams in Quality, Regulatory, Operations, Engineering, and others.
    Education and Experience
    - Bachelor’s degree or advanced in Mechanical Engineering or related field.
    - At least 8 years of experience in medical device engineering, with a focus on robotic technologies and/or instruments, EndoDrive, and camera systems.

    처우
    - Negotiable

    제출 기한
    - ASAP

    제출 서류 및 기타
    - 국/영문 이력서 및 자기소개서

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