宜昌 [切换城市] 宜昌招聘宜昌生物/制药/医疗器械招聘宜昌医疗器械研发招聘

R&D _ Mechanical Design Engineer_DIB_Shanghai

美敦力中国

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2019-11-14
  • 工作地点:上海
  • 招聘人数:若干人
  • 工作经验:无工作经验
  • 学历要求:本科
  • 职位类别:医疗器械研发

职位描述

JOB TITLE: Senior Mechanical Design Engineer BUSINESS TITLE: Senior Mechanical Design Engineer DATE: Oct, 2019 DEPARTMENT: MTC DIB

POSITION DESCRIPTION

This position is responsible for activities across the product development lifecycle, from concept generation to bringing the products to the market. The candidate should feel comfortable dealing with ambiguity, and confident about being able to apply engineering experience and principles to make pragmatic choices about design and development as well as to provide technical inputs to design assurance, process development and product registration. The candidate should have great communication and collaboration skills. Past engineering experience of developing, delivering, deploying and maintaining medical devices is required for this position.

该职位负责产品设计开发周期中涵盖的活动,从概念产生到产品上市。候选人应有能力应对不确定性,通过自身工程方面的经验和知识,在产品设计开发,设计保证,过程开发和产品注册方面做出务实的决定。候选人应该具有很强的沟通和合作能力。本职位需要在医疗器械方面工程开发,应用,配置和维护方面有着必要的经验。

POSITION RESPONSIBILITIES

工作职责

  • Design and develop mechanical components, subsystems and systems for medical device products

    设计开发医疗器械产品的机械部件,子系统和系统

  • Generates design concepts and creates/evaluates prototypes to support business decision making.

    产生概念设计,创造和评估样品以帮助市场销售部门作出决定。

  • Collaborates with peers to lead the development and/or execution of relevant engineering testing, based on internal product testing requirements and current compliance and regulatory standards.

    基于内部产品测试要求和现行法规标准要求,与同事一起开发和实施工程相关测试。

  • Generates technical reports and creates presentations as required to document and communicate results.

    撰写技术报告,PPT等交流文档。

  • Interacts with vendors and contract design/manufacturing companies for product related matters

    能够与产品相关的委托研发/生产供方一起合作。

  • Performs research & development duties, including

    实施研究和开发工作,包括

    • Test method development, design evaluation, design reviews, design specifications, design

      测试方法开发,设计评估,设计评审,设计标准,设计本身。

    • verification and validation, design transfer and OEM co-ordination.

      验证和确认,设计转移以及OEM协调。

    • Supports product risk analysis and risk management.

      支持产品风险分析和风险管理工作

    • Sources new materials, components and equipment.

      寻找新材料,部件设设备

    • Development of component spec, inspection methods, BOMs and manufacturing processes.

      部件标准,检验方法,BOM清单,生产流程制定

    • Validates product design in preclinical or/and clinical settings.

      在预临床和临床试验中验证产品设计

  • Design and develop jigs and fixtures per testing and manufacturing requirements

    根据测试和生产要求设计开发夹具,工装

  • Maintains awareness of current technological developments and accepted industry standards.

    紧跟目前技术开发前沿,获取最新工业标准

  • Coaches and motivates junior technical staff.

    教育和培训中级技术员工

  • Contributes to inventions and participates in patent disclosures writing.

    参与技术革新和专利申请的撰写。

  • Some level of travel across China will be required to visit customers, partners and attend relevant conferences.

    一定程度的国内出差以拜访客户,合作伙伴或参加相关会议。

    POSITION REQUIREMENTS

    职位要求

  1. Able to independently reviews and analyzes new designs for DFM/DFA and provides feedback to design teams.

    独立评审和分析面向生产和组装的设计并想设计小组提供反馈。

  2. Thorough understanding of clinical and regulatory pathways, IP and internal processes.

    熟悉临床和注册路径,IP申请及内部流程

  3. Demonstrates working knowledge of risk management tools, and works within a team to analyze and mitigate project risks.

    熟悉风险管理工具,与团队一起分析风险,研究风险应对措施。

  4. Able to analyze disparate data and draw reasonable conclusions.

    分析数据并提出合情合理的结论。

  5. Able to discern gaps in information and work with others to address them.

    能够识别差距并与其它团队合作弥补差距。

  6. Comfortable probing designs to ensure it is appropriate for all expected uses.

    对于设计有洞察力确定其符合所有预期用途。

  7. Able to develop complex designs to the point of manufacture and release to production.

    能够开发应用于产品制造的复杂设计,并应用于生产。

  8. Evaluates and applies design trade-offs and constraints for design optimization.

    评估和权衡设计,识别设计优化的限制条件

  9. Skilled in the use of advanced analysis tools, methods, and statistical techniques.

    能够使用先进分析工具,方法和统计技术。

  10. Able to prepare and present comprehensive design reviews.

    能够准备和演示复杂的设计评估。

  11. Able to identify gaps in requirements as a whole. Understands value of use cases.

    能够从总体上识别与要求的差距,懂得使用价值。

  12. Strong ability to work with vendors as well as contract design and manufacturing companies.

    很强的与委托设计/制造的供应商合作的能力

  13. Have excellent interpersonal, written and verbal communication skills; Individual must communicate well with all levels of management and employees as well as customers and external collaborators

    卓越的人际交往,书写和口头交流能力。个人必须能与各等级管理团队,客户及外部合作方良好交流。

  14. Knowledgeable in current and possible future policies, practices, trends, technology and information affecting own geographical area.

    了解所在区域的现有和未来潜在的政策,趋势,技术和信息。

  15. Carefully weighs the pros/cons and makes appropriate decisions based calculated risk assessment.

    小心的评估可能/结论, 基于计算的风险评估结论作出合适的决定。

  16. Explains own decisions and decision-making process while being open to feedback.

    在被询问的时候解释自己的决定及决定制定过程

  17. Evaluates new information with existing information/paradigms to create new and innovative ideas/ways of doing things.

    根据现有的信息和实例评估新信息以产生新的革新性的想法

  18. Clearly expresses ideas and concepts in writing

    清楚的书面表达想法和概念的能力

    QUALIFICATIONS AND BASIC REQUIREMENTS

    资质及基本要求

  • Education in Mechanical Engineering and/or Biomedical engineering is required.

    机械或生物医学工程专业背景优先

  • Minimum 5 years relevant experience.

    5年相关工作经验

  • Preferably minimum 2 years experience in the medical device industry.

    在医疗器械领域最少3年经验

  • Be good at Solidworks, AutoCAD and other 2D, 3D drawing software

    熟练掌握Solidworks, AutoCAD2维、3维作图软件。

  • Be familiar with Minitab or other engineering analysis tool

    熟悉Minitab或其他工程分析工具。

  • Engineering based logical thinking

    基于工程要素的逻辑思考能力

  • Solid mechanical design knowledge background and excellent design skills

    扎实的机械设计理论功底以及娴熟的设计技巧

  • Be familiar with medical device design & development process, relevant regulatory and industry standard.

    熟悉医疗器械设计开发流程,相关的法规和行业标准

  • 6sigma, DFSS, DRM, GD&T knowledge preferred

    了解6sigma, DFSS, DRM GD&T 知识优先。

  • Good English communication skills

    熟练的英语沟通能力


职能类别:医疗器械研发

关键字:研发工程师

公司介绍

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

联系方式

  • 公司地址:北京