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  • 프로젝트명
    Manufacturing Engineer – Instrument & Accessories
  • 회사개요
    외국계 의료기기 제조업체
  • 직급
    중간관리자급(과장), 실무자급(대리이하)
  • 경력
    3년 이상 ~ 8년 이하
  • 외국어
    영어3
  • 키워드
    제조,Manufacturing Engineer,ISO13485,FDA_Regulations,Medical_Devices,GMP
  • 내용
    직무 개요
    - Oversee the production line(s) and production efforts.
    - Manage and maintain clean room operations.
    - Develop and maintain process documentation, including standard operating procedures, work instructions, and process flow diagrams.
    - Maintain knowledge of design prints and approvals to ensure compliance and adherence to presented design prints.
    - Design and develop manufacturing and procedures for medical device production.
    - Collaborate with R&D on design changes, approvals and implementation.
    - Develop and maintain detailed manufacturing plans, schedules, and budgets to ensure timely delivery of products.
    - Conduct process improvement projects to optimize efficiency, reduce costs, and improve quality.
    - Collaborate with cross-functional teams including design, quality, and production to ensure successful product launch.
    - Perform root cause analysis and implement corrective actions to resolve production issues.
    - Stay up to date on industry trends, technologies, and regulations related to medical device manufacturing.

    경력 요건
    * Required Skills/Abilities
    - Demonstrated ability to manage complex medical device components.
    - Familiarity with quality standards such as ISO 13485 and FDA regulations.
    - Strong problem-solving and analytical skills.
    - Excellent communication and teamwork skills and the ability to work cross-functionally.
    - Ability to work independently, under pressure, and to handle multiple projects and tight deadlines simultaneously.
    - Knowledge of FDA Good Manufacturing Practices, ISO 13485 and 14971, 510k and Standards within Medical Devices.
    - Has experience in working in high performance organizations and fostering a positive culture with a high degree of accountability and integrity.
    - Ability to concisely communicate status, needs, forecasts, risks, and timelines effectively to executive team and all levels of the organization (one-on-one and large groups).
    - Strategic and critical thinker with the ability to analyze, understand and effectively communicate technical material to all levels of the organization.
    * Education and Experience
    - Bachelor’s degree in mechanical, industrial, or manufacturing engineering, or related field.
    - Minimum 3 years of experience in assembly line development and management.
    - Strong knowledge of manufacturing processes, equipment, and tooling.


    처우
    - Negotiable

    제출 기한
    - ASAP

    제출 서류 및 기타
    - 국/영문 이력서 및 자기소개서

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