Senior Engineer – LCM

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Position Summary:                 

Responsible for performing testing and troubleshooting of sequencing instrumentation. Work with team to support product transfer. Other responsibilities include failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement.

负责对测序仪器进行测试和故障排除。与团队合作，支持产品导入。包括故障分析、质量改进、流程改进、降低成本、工程评估和系统改进。

Position Responsibilities:

• 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 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。
• 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。

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

所列职责是与该职位相关的基本职责，但并非详尽无遗。个人职责可能会因业务需要而发生变化。

Position Requirements:

• 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。

All listed requirements are deemed as essential functions to this position.

所有列出的要求都被视为该职位的基本职能要求

Preferred Experience/Education/Skills:

• 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。

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.