Engineer 2 – 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.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:                 

Work with team to support product transfer. Other responsibilities include failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement.

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:

• 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。

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 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。

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
• 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。

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.