Engineer 2 – LCM
- Shanghai
- Permanent
- Full-time
- Complete Non-conformance Records based on the investigation and drive the release of products back to production.
- Establish and maintain databases of products failures and defects. Perform data trending analysis, construct and execute design of experiments to address yield and quality issues.
- Support and drive activities to ensure successful product transfer into manufacturing.
- Write and update work instructions as needed to improve test procedures.
- Participate actively and able to do troubleshooting, problem solving, failure analysis, root cause, and corrective action processes as required under the guidance
- Carry out design experiments, perform analytical measurements and interpret results of system and sub-system level testing to qualify or resolve product and process issues.
- Support the definition, design, development, testing, and validation efforts for product enhancements.
- Apply various analysis techniques, such as FMEA and statistical analysis to optimize product quality and minimize cost, providing all calculations and performance data required on new and existing products.
- Manage and coordinate Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes.
- Carry out documentation responsibilities include, but not limited to, generating Bill of Materials, test reports, assembly procedures.
- Work closely with contract manufacturing partners and key suppliers to ensure smooth transition of quality products from development into manufacturing.
- 在调查的基础上完成不合格记录，并推动产品重新投入生产。
- 建立并维护产品故障和缺陷数据库。推动并实施流程改进和产品维护活动，以实现生产目标。
- 支持和推动各项活动，确保产品成功转入生产。
- 根据需要编写和更新作业指导书，以改进测试程序。
- 积极参与并能够在指导下根据要求完成故障排除、问题解决、故障分析、根本原因分析和纠正措施流程
- 开展设计实验、执行分析测量并解释系统和子系统级测试结果，以鉴定或解决产品和流程问题。
- 支持产品改进的定义、设计、开发、测试和验证工作。
- 应用各种分析技术，如 FMEA 和统计分析，优化产品质量，降低成本，提供新产品和现有产品所需的所有计算和性能数据。
- 管理和协调工程变更单实施活动，包括报废分析、物料处置、更新作业指导书和测试要求变更。
- 履行文档编制职责，包括但不限于生成材料清单、测试报告、装配程序。
- 与OEM和主要供应商密切合作，确保优质产品从开发到制造的顺利过渡。
- Strong analytical skills, problem solving and troubleshooting.
- Demonstrated ability in developing Work Instructions, and Writing reports.
- Experience with NMPA regulated medical device manufacturing
- Must thrive in fast-paced, dynamic environment
- Strong verbal and written communication skills.
- Familiar with engineering tools such as, statistical analysis, design of experiments, product and process capability analysis.
- 较强的分析能力、解决问题和排除故障的能力。
- 具备编写作业指导书，流程文件、撰写报告的能力。
- 具有NMPA监管的医疗器械生产经验
- 能适应快节奏
- 较强的口头和书面沟通能力。
- 掌握工程工具，如统计分析、实验设计、产品和流程能力分析。
- Typically requires a Bachelor’s degree
- 3+ years preferred working experience in Life Science Industry (Medical Device is preferred)
- Product development experience in the life sciences, biotech, biomedical preferred.
- 至少获得学士学位
- 有3 年以上生命科学行业（医疗器械优先）工作经验者优先。
- 有生命科学、生物技术、生物医学行业产品开发经验者优先。