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Tech.ops Engineer (Mechanical)_Suzhou in Suzhou, China at Beckman Coulter Diagnostics

Date Posted: 4/11/2019

Job Snapshot

Job Description

Job ID: BEC014117

About Us

Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems, protein chemistry systems, urinalysis systems, microbiological detection and analysis systems, and blood bank analytical systems. In future developments, Beckman Coulter will continue to lead in the field of medical equipment research and development with cutting-edge technology and complete product lines, and continue to make outstanding contributions to the development of global scientific research! For more information, please visit www.beckmancoulter.com.


Description

本岗位工作偏重于“产品、系统”中的新产品引进和系统技术符合等方面与新产品符合直接相关的技术转移和产品上市活动。工作范围包含(新)产品标签和说明书的设计、新产品注册等方面的技术文件(报批文件)等, 在技术部从事所分配的技术符合工作,包含:
l 新产品法规符合活动(产品标签设计、注册技术材料起草等);
l 新产品技术符合活动(产品批量试验、产品技术资料起草等)。
主要职责:
1. 负责上述一个或多个领域的技术符合工作,了解技术符合和法规符合要求;
2. 标签、说明书的设计,包含文字、内容、图标等符合法规和顾客要求。
3. 包装材料(PPM/BPM/GPM)标准、测试文件的起草和维护。
4. 熟悉Phoenix 标签管理系统并能熟练利用图片编辑软件进行设计和修改。
5. 熟悉IVD产品注册流程,起草(新)产品一般注册资料和政府一般报告。
6. 参与新产品法定机构的注册检测和注册过程中的质量体系审核。
7. 收集(新)产品总部技术资料,包括DMR、标签、MSDS、IFU等。
8. 收集(新)产品总部研发资料,包括 临床报告、CIS、检验报告 等。
9. 收集(新)产品市场预期需求,包括 产品运输条件、每月发货量等。
10. 通过各种途径(如Global CAPA,DID3)收集产品相关CFF/DR 报告。
11. 翻译整理资料,起草产品Profile,包含产品介绍、预期产量、生产频率等。
12. 新原料标准、检验程序的起草并参与指导采购和使用方面的技术要求。
13. 起草(新)产品DMR(A版本),并用于指导产品小试。
14. 建立(新)产品Quality Trend 表,并对测试数据进行分析和总结。
15. 更新(新)产品DMR(B版本),并用于指导产品中试。
16. 追踪(新)产品验证方案的实施,包含稳定性、加速及挑战性试验等。
17. 了解某个产品实现的全部过程,包含研发、注册、生产、检验和服务。
18. 了解各产品种类、规格、配方、原理、应用要求,熟悉产品的整套文件。
19. 了解临床诊断分析仪器的原理、应用、验证、临床使用和临床结果判别。
20. 完成技术符合主管安排的其他工作。

Job Requirements



Qualifications

l 1.生物医学、临床检验类相关专业,本科三年(或硕士一年以上)工作经验;
l 2.良好的英语沟通(英文报告和流利口语)能力;
l 3.接受过全面的相关法律法规培训(如IVD-GMP等)和产品技术培训;
l 4.努力完成计划内外的各项要求,发现问题和改进的意愿和贡献;
l 5.过程疑难问题的调查和解决能力,计划能力和自我管理和发展的能力;
l 6.良好的管理时间技巧,掌握轻重缓急。
l 7.良好的电脑应用技能,部门内部和外部沟通的能力;
l 8.当遇到困难、压力、挫折时,努力展示自己的韧性。

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.