【资深工艺工程师高级工艺工程师 Lead Industry Engineer II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 Lead Industry Engineer II (P2b) 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 moderate level of guidance and direction. This position may assist to provide guidance to new team members. 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 moderate level of guidance and direction. 2. Designs and reviews fixtures and/or gauges to support develop and optimize manufacturing of Core Histology products (mechanical orientation engineer). 3. Designs and reviews programs and/or devices to support develop and optimize manufacturing of Core Histology products (electrical orientation engineer). 4. Writes the specification and acceptance criteria of production equipment. 5. Executes the installation and verification of production equipment, manufacturing process and/or software. 6. Prepares, maintains, and reviews the process documents as per the requirement 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. Use technical experience and judgment and precedents to solve problems and improve manufacturing. 10. Acts as team member in small projects with manageable risks and resource requirements. 11. Assist in acting as a resource on process documents, process development, fixture design, equipment development to new team members. 12. Take on new tasks. Person Specification： Skills / Competencies 1. Ability to solve problems in straightforward situations without coaching by using quality tools and DBS tools. 2. Ability to act as a team member in small teams or projects. 3. Ability to develop, maintain, improve, and review of manufacturing process. 4. Ability to design and review fixtures, and/or gauges (mechanical orientation engineer). 5. Ability to design and review programs, and/or devices (electrical orientation engineer). 6. 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. 7. Ability to assist in providing informal guidance to new team members. 8. Good team collaboration. 9. Self-motivated. 10. Act initiatively and proactively. 11. Sense of urgency to drive result and moving project forward. 12. Good communication skill. Explains difficult or sensitive information; works to build consensus. 13. Nimble learning. 14. Good integrity. Functional knowledge Demonstrates and applies expanded conceptual knowledge in own discipline and with an understanding of related disciplines Business expertise Uses understanding of key business drivers to prioritize accomplish own work. Leadership No supervisory responsibilities but provides informal guidance to new team members. Problem solving Solves problems in straightforward situations without coaching; analyses possible solutions using technical experience and judgment and precedents. Impact Impacts quality of own work and the work of others on the team; works within guidelines and policies. Education Bachelor’s degree in Mechatronics/Mechanical/Automation/Electrical Engineering, or related field. Experience 1. Minimal 5 years of experience in process development and improvement, includes minimal 2 years of experience in process development of medical devices. 2. Understanding of ISO, FDA and NMPA requirements for the manufacturing of medical devices. Travel Less than 10 %, must be able to travel domestically and internationally Language Native Chinese & Good English

其他信息: 语言要求：不限; 行业要求：医疗器械

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