Sr Engineer – LCM
- Shanghai
- Permanent
- Full-time
- Troubleshoot and resolve hardware, firmware, software, and chemistry/reagent problems on complex systems (e.g. Instruments with optical & fluidics sub-systems) to support product manufacturing and customer solutions.
- Complete Non-conformance Records based on the investigation and drive the release of products back to production.
- Participate in Project Core Teams to drive the release of quality products into manufacturing and transfer new products from global into China manufacturing.
- Manage project includes creation and maintenance of detailed project plans and schedules for team members, provide status reports and make presentations.
- Write and update work instructions as needed to improve test procedures.
- Participate actively and able to independently in troubleshooting, problem solving, failure analysis, root cause, and corrective action processes as required
- 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.
- Provide guidance and supervision to junior engineer.
- 排除和解决基因测序仪（如带有光学和液路系统的基因测序仪）的硬件、固件、软件和化学/试剂等问题 以为产品制造和客户解决方案提供支持。
- 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。
- 参与项目核心团队，推动将优质产品投入生产。将新产品从国外转移到中国生产。
- 项目管理包括为团队成员创建和维护详细的项目计划和时间表，提供状态报告并进行演示。
- 根据需要编写和更新作业指导书，以改进测试程序。
- 积极参与并能够根据要求独立完成故障排除、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、材料处置、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。
- 为初级工程师提供指导和监督。
- Strong analytical skills, problem solving and troubleshooting.
- Demonstrated ability to use statistical tools in data analysis and problem solving.
- Demonstrated ability in developing Work Instructions, Writing and Presenting reports.
- Experience with NMPA regulated medical device manufacturing
- Strong organizational skills, attention to detail and accuracy, and the ability to work independently and in a team environment are essential.
- Must thrive in fast-paced, dynamic environment
- Strong verbal and written communication skills.
- 较强的分析能力、解决问题和排除故障的能力。
- 具有使用统计工具分析数据和解决问题的能力。
- 具备编写作业指导书，流程文件、撰写报告和汇报的能力。
- 具有NMPA监管的医疗器械生产经验
- 必须具备较强的组织能力，注重细节和准确性，能够独立工作，也能在团队环境中工作。
- 能适应快节奏
- 较强的口头和书面沟通能力。
- Typically requires a Bachelor’s degree (Preferred to have Bioengineering, Science or Engineering)
- 5+ years preferred working experience in Life Science Industry (Medical Device is preferred) with knowledge in DNA Sequencing//Liquid Handling Robot and systems testing – hardware, firmware, software, and chemistry/reagents.
- Experience in various laboratory analytical instrumentation and techniques (Nanodrop, Spectrometer, PCR, pH Meter, etc.) will be an added advantage.
- 至少获得学士学位（生物工程、科学或工程学优先）
- 有 5 年以上生命科学行业（医疗器械优先）工作经验者优先，熟悉 DNA 测序/液路处理机器人和系统测试（硬件、固件、软件和化学/试剂）。
- 具有各种实验室分析仪器和技术（纳米滴定仪、光谱仪、聚合酶链反应仪、pH 计等）方面的经验者优先。