【资深工艺工程师高级工艺工程师 Senior Industry Engineer I招聘】

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资深顾问(SC) · 上海帝博企业管理咨询有限公司

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职位介绍: Purpose/Objective: The Senior Industry Engineer I (P3a) is responsible for process development, maintaining and improvement of new projects and launched projects while ensuring compliance to procedures, specifications, and regulatory guidelines, provided with best practice and minimal guidance and direction. The Senior Industry Engineer I act as a resource for team members with less experience. The position may lead small projects with manageable risks and resource requirements. Area of Responsibilities: 1. Ensures the quality of process development, maintaining and improvement of new projects and launched projects while ensuring compliance to procedures, specifications, and regulatory guidelines, provided with best practice and minimal guidance and direction. 2. Implement of new technologies for manufacturing of microscopes and accessories. 3. Designs and reviews fixtures and/or gauges to support develop and optimize manufacturing of microscope. 4. Writes and reviews of the specification and acceptance criteria of production equipment. 5. Executes and leads the installation and verification of production equipment, manufacturing process and/or software. 6. Prepares, maintains, and reviews the process documents as per requirements of ISO, NMPA, FDA. 7. Integrates EHS requirements into manufacturing process and daily activities to ensure safe working environment for all associates. 8. Integrates quality requirements into manufacturing process; forecast and mitigate quality risks throughout product lifecycle. 9. Uses the best practice and in-depth knowledge to solve complex problems and improve manufacturing. 10. Acts as key member in functional teams or projects and impact others with in-depth knowledge and experience. 11. Acts as a resource on process documents, process development, fixture design, equipment development to new team members. Person Specification： Skills / Competencies 1. Ability to solve complex problems by effectively using quality tools and DBS tools. 2. Ability to leads small projects with manageable risks and resource requirements. 3. Ability to develop, maintain, improve, and review of manufacturing process. 4. Ability to design and review fixtures, and/or gauges. 5. Ability to integrate quality requirements and EHS requirements into manufacturing process; forecast and mitigate quality risks and safety risks throughout manufacturing process and product lifecycle. 6. Act initiatively and proactively. 7. Sense of urgency to drive result and moving project forward. 8. Good communication skill. Explains difficult or sensitive information; works to build consensus. Functional knowledge 1. Proficiency in Matlab and Multisim or Proteus software for PCBA analysis. 2. Strong knowledge and understanding of hardware, software design and structure diagram. 3. Familiar with circuit analysis methods, such as the application of basic Ehrhoff's law 4. Familiarity with medical device regulations and standards. 5. Prior experience in designing and developing Class II medical devices (combination software) is a plus. Leadership No supervisory responsibilities but provides informal guidance to new team members. Problem solving Solves complex problems, leveraging PSP methodology, with some coaching; takes a new perspective on existing solutions; exercises judgment based on limited set of data. Impact Impacts quality of own work and the work of others on the team; works within guidelines and policies. Education Bachelor’s degree in Electronic Engineering, Mechatronics Engineering, or related field. Experience 1. Minimal 8 years of experience in process development and improvement, includes minimal 3 years of experience in process development of medical instruments. 2. Deep understanding of the specifications, development, and manufacturing processes of 2nd Class Medical Devices. Travel Less than 15 %, must be able to travel domestically and internationally. Language Native Chinese & Fluent English.

其他信息: 语言要求：英语; 行业要求：医疗器械

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