Product and Validation Engineer

Key Responsibilities Product Verification and Validation Develop and execute application-level test plans, protocols, and reports for organoid culture, synthetic biology (e.g., clone screening, cell culture, PCR, centrifugation, plate handling), and spatial omics workflows. Conduct functional, performance, reliability, and robustness testing of instruments and end-to-end automated workflows, including throughput, accuracy, precision (CV), reproducibility, and contamination control. Define acceptance criteria and key performance metrics together with R&D and product management, aligned with customer use cases and competitive benchmarks. Identify, document, and track defects and performance gaps ; drive root-cause analysis and verify corrective actions with engineering teams. Instrument Operation & Workflow Development Rapidly master and proficiently operate life sciences instruments , such as imaging systems/high-content screening, liquid handlers, incubators, centrifuges, thermal cyclers, plate readers, and sequencing-related equipment. Design and optimize application protocols and SOPs for integrated workcells and autonomous lab workflows, from sample preparation to data output. Support data analysis and interpretation of biological and instrument data (e.g., imaging, cell viability, gene expression, spatial data) to assess system performance. Customer Engagement & Field Validation Act as a technical interface with customers , conducting demos, beta/site testing, customer evaluations, and application training. Capture voice of customer (VOC) and field issues, translating them into clear product requirements and improvement recommendations . Support pre-sales and post-launch application support , including application notes, technical presentations, and troubleshooting. Quality, Documentation & Compliance Author and maintain test protocols, test reports, application notes, user guides, and training materials in alignment with design control and quality system requirements. Ensure traceability from user requirements to verification and validation results; support design reviews, launch readiness, and product release decisions. Follow laboratory safety, biosafety, and quality standards (e.g., GLP practices, ISO-aligned QMS). Collaboration & Continuous Improvement Collaborate cross-functionally with R&D, Systems, Software, Quality, Manufacturing, Marketing, and Service teams to ensure successful product delivery. Serve as a bridge between customers, application, and engineering teams : communicate test results, risks, and priorities clearly, and drive alignment and timely resolution of cross-functional issues. Continuously learn new technologies, instruments, and applications (e.g., emerging organoid, synthetic biology, spatial omics, and AI-enabled lab automation) and apply them to improve testing and workflows. Contribute to test methodology standardization , reusable test assets, and test automation where applicable. Share application know-how and support knowledge transfer to sales, service, and application teams. Required Qualifications Bachelor’s or Master’s degree in Biology, Cell Biology, Molecular Biology, Bioengineering, Biomedical Engineering , or a related field. 3+ years of hands-on experience in life sciences laboratories, application support, product testing, or instrument verification, preferably in the life science tools or diagnostics industry. Practical experience in at least one of: organoid / 3D cell culture, synthetic biology, or spatial omics (spatial transcriptomics/proteomics, multiplex imaging). Strong learning agility : able to quickly learn new scientific domains, instruments, and software, and become proficient in operating laboratory instruments in a short time, with solid experimental design and troubleshooting skills. Proficiency in data analysis (Excel, GraphPad, or Python/R) and statistical evaluation of performance data. Excellent cross-functional communication and collaboration skills ; able to work effectively across R&D, quality, product management, and commercial teams, and to drive alignment in a matrix organization. Strong customer-facing skills ; able to explain technical results clearly to customers and internal stakeholders. Good written and spoken English. Preferred Qualifications Experience with lab automation platforms, integrated workcells, or high-content imaging systems. Experience with product verification & validation in a regulated or design-controlled environment (life sciences, IVD, or medical devices). Familiarity with bioinformatics or image analysis tools (e.g., spatial omics analysis pipelines, AI-based cell segmentation). Experience with beta testing, customer evaluations, or field application support . Willingness to travel to customer sites as needed; experience working in cross-site or global teams . 产品及验证工程师 职位概述 产品验证工程师 是新一代 类器官、合成生物学、空间组学系统及本土设计的创新产品 质量保障与市场成功的关键贡献者。该岗位负责从 终端用户应用视角 ，对仪器、自动化工作流、试剂及软件进行 功能与性能验证的规划和执行 ，确保产品在上市前后均满足客户需求。 该岗位与 研发、系统、自动化、软件、质量、产品管理及应用支持团队 紧密合作，并直接对接 客户和关键意见领袖（KOL） ，验证真实应用场景下的工作流程，将现场反馈转化为产品改进。 理想候选人应是 学习能力强、具备出色跨部门沟通能力 的人，能够快速掌握新技术、新仪器和新应用，并推动各方围绕质量和客户价值达成一致。 主要职责 应用验证与产品验证 制定并执行 应用层面的验证计划、方案和报告 ，覆盖类器官培养、合成生物学（如克隆筛选、细胞培养、PCR、离心、板处理）及空间组学工作流。 开展仪器及端到端自动化工作流的 功能、性能、可靠性和稳健性验证 ，包括通量、准确度、精密度（CV）、重复性及污染控制。 与研发和产品管理共同定义 验收标准和关键性能指标 ，确保与客户应用场景及竞品对标一致。 识别、记录并跟踪 缺陷与性能差距 ；推动根因分析，并与工程团队验证纠正措施。 仪器操作与工作流开发 快速掌握并熟练操作 生命科学仪器 ，如成像/高内涵筛选系统、移液工作站、培养箱、离心机、PCR 仪、酶标仪及测序相关设备。 为集成工作站及自动化实验室工作流设计和优化 应用方案和 SOP ，覆盖从样本制备到数据输出的全流程。 支持生物数据及仪器数据（如成像、细胞活力、基因表达、空间数据）的 分析与解读 ，评估系统性能。 客户沟通与现场验证 作为 客户技术接口 ，开展丹纳速创系统产品演示、Beta/现场验证、客户评估及应用培训。 收集 客户之声（VOC） 及现场问题，转化为清晰的 产品需求和改进建议 。 支持 售前及上市后应用支持 ，包括应用笔记、技术演讲及问题排查。 质量、文档与合规 按照设计控制和质量体系要求，编写并维护 验证方案、验证报告、应用笔记、用户指南及培训材料 。 确保从用户需求到验证与确认结果的 可追溯性 ；支持设计评审、上市准备及产品发布决策。 遵守 实验室安全、生物安全及质量标准 （如 GLP 规范、符合 ISO 的质量管理体系）。 协作与持续改进 与 研发、系统、软件、质量、生产、市场及服务团队 开展跨部门协作，确保产品成功交付。 作为 客户、应用与工程团队之间的桥梁 ：清晰传达验证结果、风险和优先级，推动跨部门问题的协同与及时解决。 持续 学习新技术、新仪器和新应用 （如前沿类器官、合成生物学、空间组学及 AI 驱动的实验室自动化），并应用于验证和工作流改进。 推动 验证方法标准化 、可复用验证资产建设，并在适用时推进验证自动化。 分享应用经验，支持向销售、服务及应用团队的 知识转移 。 任职要求 生物学、细胞生物学、分子生物学、生物工程、生物医学工程 或相关专业本科及以上学历。 3 年以上 生命科学实验室、应用支持、产品验证或仪器验证的 实操经验 ，有生命科学工具或诊断行业经验者优先。 至少具备以下一个领域的实践经验： 类器官/3D 细胞培养、合成生物学或空间组学 （空间转录组/蛋白组、多重成像）。 学习能力强 ：能够快速学习新的科学领域、仪器和软件，短时间内熟练操作实验室仪器，具备扎实的实验设计和问题排查能力。 熟练使用 数据分析工具 （Excel、GraphPad 或 Python/R），能够对性能数据进行统计评估。 出色的跨部门沟通与协作能力 ；能够与研发、质量、产品管理及商务团队高效合作，在矩阵型组织中推动共识。 良好的 客户沟通能力 ，能够向客户和内部相关方清晰阐述技术结果；英文读写和口语良好。 优先条件 具备 实验室自动化平台、集成工作站或高内涵成像 系统使用经验。 具备受监管或设计控制环境下的 产品验证与确认 经验（生命科学、IVD 或医疗器械）。 熟悉 生物信息学或图像分析工具 （如空间组学分析流程、基于 AI 的细胞分割）。 具备 Beta 验证、客户评估或现场应用支持 经验。 能够根据需要 出差至客户现场 ；有 跨地域或全球团队 协作经验者优先。 Join our winning team today. 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