医疗器械设计工程师
苏州艾斯艾工业工程服务有限公司SuzhouUpdate time: July 28,2019
Job Description
苏州市 工业园区
The Mechanical Design Engineer as part of a product development team is generating design documents to given system specifications and module specifications for optical instruments in the fields of microscopy and medical devices.

1.1 Work effectively as a dedicated team member in a joint development team including overseas engineers to develop new products for China and European or US markets.

1.2 Develop and analyze design concepts according to given systems or module specifications. Design for ease of manufacture and service.

1.3 Generation of mechanical design documents and technical drawings for medical products.

1.4 Conduct design verifications and design reviews. This can include basic thermal and stress calculations etc. as well as the checking of drawings for conformity with drawing standards, for technical consistency and for safety.

1.5 Providing necessary technical documents and information for the development process to the Quality Assurance responsible in a development project. Define of critical dimensions and participate in creating design verification test plans and first article inspection plans (critical dimensions).

1.6 The scope of design jobs is including designs for products as well as for test equipment, prototypes and assembly- and adjustment equipment for these products.

1.7 Participate in prototype assembly, verification testing, troubleshooting.

1.8 Consulting function during the Design Transfer and production ramp-up phase of the development project.

1.9 Generate module- and system validation plans together with project partners in development projects. Perform/Support endurance tests, definition of life cycles and realize them in products. Definition of adequate qualification procedures together with application specialists.

1.10 Design-maintenance of modules and components of future systems.

1.11 Other duties, as assigned.

2.0 GENERAL REQUIREMENTS

2.1 A Bachelor’s degree in Mechanical Engineering or related field with a minimum of 4-5 years working experience in Mechanical Design, preferably in the field of optical instruments or medical devices. An advanced degree, such as a Master’s Degree is advantageous and might substitute some years of experience.

2.2 Competent in mechanical design (3D modeling and 2D drafting) with Pro-E; knowledge about other 3-D CAD systems (Autocad & Solidworks). Experience with PLM software (preferably SAP).

2.3 Familiar with design in product development projects and design control processes. Familiarity with ISO 9001, ISO 13485, IEC 60601 3rd edition is a plus.

2.4 Experience in Validation Test Planning and/or Validation Test Execution.

2.5 Experience in designing different kinds of parts, such as: Machined (multiple axis CNC, multiple axis lathe) parts, die cast parts, injection molded and plastic parts, sheet metal parts. Familiar with design to cost principles.

2.6 Familiar with design for thermal, humidity, shock and vibration or with the design of precision mechanical assemblies or opto-mechanical mount design is a big plus.

2.7 Familiar with geometrical dimensioning and tolerancing (ISO-standards) and how to inspect tolerances. Experience in tolerance budgets and analysis.

2.8 Familiar with production equipments and testing instruments (like CMM, CNC-programming). Experience in Quality Control is a plus. Experience in lathe and mill operation is advantageous.

2.9 Creativity, one’s own initiative, analytical skills and judgment.

2.10 Good command of English, both oral & written.

2.11 Excellent communication and teamwork skills

2.12 Strong analytic and problem solving skills

2.13 Ability to prioritize and handle multiple tasks

2.14 Some travel within China and abroad might be required. Occasional overtime work might be necessary.

职能类别: 医疗器械研发

关键字: 医疗机械设计

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上班地址:苏州工业园区华池街时代广场24A国际金融中心510室


公司信息

苏州艾斯艾工业工程服务有限公司原名卡德康(苏州)工业工程服务有限公司,公司总部设于德国的奥格斯堡,是德国著名的工业设计服务供应商。2015年卡德康和SII艾斯艾集团合并后,在全球范围有16个分支机构,全球员工超过5000人,年度销售额超过4,000万欧元。
公司业务涵盖了六大领域,包括汽车,普通机械,医疗器械,航天航空,工厂规划和特种机械制造。
在每个领域中,公司按需提供三种服务,即工程技术服务,生产制造服务和人力资源服务。

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