医疗器械工艺高级工程师 广州

月薪： 0.8-1.5万/月

该公司所有职位
  • 1年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 免费班车
  • 专业培训
  • 年终奖金
  • 定期体检
  • 补充福利计划
  • 年底双薪
  • 免费工作餐

职位描述

职位描述： Main Job responsibilities:1.Apply knowledge of general engineering principles, materials, DFMEA & reliability to achieve product design requirements.2.Define, qualify and work with vendors for prototype tool fabrication, sample preparation and manufacturing mold qualification and design verification and validation.3.Establish appropriate testing strategy to insure adequate safety factors or margins.4.Perform product testing to insure adequate safety factors or margins.5.Work with vendors and internal expert to define, source and approve appropriate materials for medical device uses.6.Develop & monitor project plan, budget, contingency plans & work estimation.7.Coordinate integration of complex sub-system product designs.8.Work with vendors and regulatory affairs to register medical device and ensure to meet all the mandatory and/or specific product specifications.9.Other responsibilities may be assigned & not all responsibilities listed may be assigned.10.Work Environment: Office, laboratory, surgical and manufacturing facilities.11.All employees are responsible for minimizing both the environmental and health and safety effects of the work that they perform.;Qualification and requirements:1.Sound knowledge in R&D process/system;2.Familiar with at least two of following technical aspects:a.Free-body & stress-strain analysis & FEA (finite element analysis);b.Geometric tolerance & tolerance stack-up analysis (GD&T)c.Gage repeatability & re-calibration system & methodologyd.Plastic resins, ferrous & nonferrous metals, adhesives & sealants;3.Solid experience to develop and validate mechanical device manufacturing processes, experience in medical delivery device is a plus.4.Solid experience to work with vendors and deep understanding of mold fabrication and device manufacturing.5.Good English communication skills;6.Relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills;Education and experience:1.Bachelor's degree in an engineering discipline with at least 6 years, MS with at least 3 years, or PhD with at least 1 years of relevant experience in mechanical or chemical engineering related major, medical device experience is preferred.2.Special design analysis software, (e.g., FEA, mold flow) and CAD / CAM software proficiency is required.3.Experience in project management is preferred; 职能类别： 医疗器械研发 关键字： 医疗器械 工艺工程师

联系方式

广州市萝岗区科学城瑞泰路5号

公司信息

广州倍绣生物技术有限公司(以下称“倍绣”)是强生在华的全资子公司。倍绣最早成立于1995年，位于中国广东省广州市，是专业从事技术开发、研制、生产猪源性生物制品的生物技术公司。2013年5月2日，强生（中国）投资有限公司（以下称“强生”）成功收购倍绣，这也是强生医疗进入中国市场20多年以来的第一次在中国的收购。目前，倍绣已经设有完善的生产线，员工人数将近160人。 倍绣成立之初，自主研发了从哺乳动物血中提取纤维蛋白原和凝血酶的技术。倍绣采用该技术所生产的猪源纤维蛋白粘合剂（又称“倍绣胶”），是中国首个作为药品获得国家食品药品监督管理局批准的动物源纤维蛋白胶产品，并成为中国首个获得药品GMP证书的产品。倍绣胶具有天然封闭、快速愈合的特点，可广泛应用于各种手术创面、腔镜手术及内窥镜治疗，能提高手术质量，减轻患者痛苦，促进创伤自然愈合，有效地帮助医生挽救病患的生命。 倍绣在业务上将与强生旗下的爱惜康公司紧密结合，通过强强联手从而开拓更多的创新临床方案，以解决在外科手术中的止血等问题。倍绣胶对爱惜康现有的生物外科产品线将会是一个很好的补充，丰富产品组合，为引进先进的生物技术方案创造了新的机会，以满足外科医生及病患的不同需求。 倍绣以强生《我们的信条》作为公司及员工的共同价值观。它是强生百年保持不变的原则与理念，它指导企业无论是在确定发展方向或是制订公司决策时，皆要以提倡健康与推动公益为宗旨。并关注我们的客户，关注自己的员工、关注社会、关注股东的利益。它是公司成长的动力源泉，持续为企业引导正确的方向与目标。它赋予公司更高的价值，并提供客观的道德判断标准。它将在每一个倍绣的员工的心中继续被弘扬，被付诸实践。

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