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 2-3 years working experience in Mechanical (Product) Design, preferably in the field of optical instruments or medical devices.
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 injection molded and plastic parts. Bewareness of cost.
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 Good command of English, both read & written. German is a plus.
2.9 Excellent communication and teamwork skills.
2.10 Strong analytic and problem solving skills
职能类别: 医疗器械研发
关键字: 医疗 机械 研发 设计
联系方式
上班地址:上海自由贸易试验区
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