Supplier Development Engineer

Supplier Development Engineer (PCBA) | 供应商开发工程师（PCBA）

Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.

Heartstream 秉承 40 余年来在急救医疗技术领域持续增长与创新的深厚积淀，始终坚定践行我们的使命： 挽救生命、降低医疗成本，并推动复苏医学的发展 。我们服务于公共场所 AED（自动体外除颤器）、院前急救服务（EMS） 军事以及医院等多个市场领域。Heartstream 旗下拥有众多业内领先的品牌和产品，包括 HeartStart AED 自动体外除颤器系列 、 Intrepid 和 DFM100 监护除颤仪 、 Tempus 监护仪及 Tempus ALS 高级生命支持系统 ，以及 Corsium 和 ECI 医疗信息化解决方案 。

Your Impact

As a Supplier Development Engineer, you will play a critical role in ensuring the quality, reliability, and manufacturability of components and products supplied across Heartstream's global supply base. Working closely with suppliers, Engineering, Quality, Operations, and Procurement teams, you will drive quality excellence from supplier selection through product launch and throughout the product lifecycle.

You will serve as a core quality representative on New Product Introduction (NPI) projects, applying Advanced Product Quality Planning (APQP) methodologies and supplier quality best practices to ensure components and finished products consistently meet Heartstream's quality, regulatory, and performance requirements.

您的影响力

作为一名 供应商开发工程师（Supplier Development Engineer ，您将在确保 Heartstream 全球供应链中所采购零部件和产品的 质量、可靠性及可制造性 方面发挥关键作用。您将与供应商，以及工程、质量、运营和采购团队紧密合作，从供应商遴选到产品上市，再到产品全生命周期管理的各个阶段，持续推动卓越质量标准的落实与提升。

您将作为 新产品导入（NPI, New Product Introduction）项目 中的核心质量代表，运用 先进产品质量策划（APQP, Advanced Product Quality Planning）方法论及供应商质量管理最佳实践，确保零部件和最终产品始终满足 Heartstream 在质量、法规合规性及产品性能 方面的要求和标准

In this role, you will:

• Lead supplier quality activities during product industrialization and New Product Introduction (NPI) projects.
• Evaluate and qualify new suppliers, ensuring they meet Heartstream's technical, quality, and manufacturing requirements.
• Partner with suppliers and engineering teams to proactively identify and mitigate manufacturing and quality risks before product launch.
• Drive APQP deliverables and PPAP approvals to ensure successful production readiness.
• Facilitate Design for Excellence (DfX) activities, leveraging supplier expertise to optimize product quality, manufacturability, and cost.
• Support supplier development and continuous improvement initiatives that enhance product quality, delivery performance, and operational excellence.
• Develop expertise in supplier quality management within a highly regulated medical device environment while contributing directly to products that help save lives.

在此职位中，您将：

• 主导产品工业化和**新产品导入（NPI）**项目中的供应商质量管理工作。
• 评估并认证新供应商，确保其满足 Heartstream 在技术、质量和制造能力方面的要求。
• 与供应商及工程团队紧密合作，在产品上市前主动识别并降低制造及质量风险。
• 推动**先进产品质量策划（APQP）各项交付成果的完成以及生产件批准程序（PPAP）**的审批工作，确保产品顺利具备量产条件。
• 组织和推动**卓越设计（DfX，Design for Excellence）**活动，充分利用供应商的专业知识，优化产品质量、可制造性及成本。
• 支持供应商发展及持续改进项目，不断提升产品质量、交付绩效和运营卓越水平。
• 在高度监管的医疗器械行业环境中积累和深化供应商质量管理专业能力，同时直接参与帮助挽救生命的重要产品开发与交付工作。

Our Commitment to Collaboration

• Your work will directly improve the quality of emergency medical services and enhance patient safety and survival rates by making high-quality care accessible to more people around the world. As part of a number one provider of therapeutic care solutions, your contribution will help us continue to save more lives every year. With every project, you'll be making a world of difference.
• We believe collaboration is better together than apart. This role is office-based 4 days per week and will be located in Shenzhen, China. You will also get the opportunity to travel to contract manufacturers in Thailand and Malaysia.

我们对协作的承诺

• 您的工作将直接提升急救医疗服务的质量，并通过让更多人能够获得高质量医疗护理，进一步提高患者安全水平和生存率。作为全球领先治疗护理解决方案提供商团队的一员，您的贡献将帮助我们每年挽救更多生命。通过参与每一个项目，您都将在改善全球医疗健康事业中发挥重要作用。
• 我们相信，面对面的协作比单独工作能够创造更大的价值。本职位为 每周 4 天办公室办公模式 ，工作地点位于 中国深圳 。同时，您还将有机会前往位于**泰国和马来西亚的合同制造商（Contract Manufacturers）**进行业务交流和现场支持，深入参与供应链质量管理和制造运营活动。

You'll Thrive in the Role If:

• You have a Bachelor's degree in Engineering, Electrical Engineering, Electronics Engineering, Supply Chain Management, Manufacturing Engineering, Quality Engineering, or a related discipline.
• You have previous experience with Printed Circuit Board Assembly (PCBA).
• You bring experience in supplier quality, manufacturing quality, process engineering, product quality, supplier development, or new product introduction environments.
• You have working knowledge of:
• Advanced Product Quality Planning (APQP)
• Production Part Approval Process (PPAP)
• Process Failure Mode and Effects Analysis (PFMEA)
• Measurement System Analysis (MSA)
• Statistical Process Control (SPC)
• First Article Inspection (FAI)
• Process Validation and Verification (PV&V)
• Corrective and Preventive Actions (CAPA)
• Supplier Quality Management Systems
• You are comfortable reviewing technical drawings, specifications, manufacturing processes, and quality requirements.
• You possess strong problem-solving skills and can use data to identify root causes and develop effective corrective actions.
• You have strong communication and influencing skills and can effectively partner with suppliers and cross-functional stakeholders.
• As our global business language is English, we require you to be confident speaking, writing and reading English.
• You demonstrate a continuous improvement mindset and enjoy working in fast-paced product development and manufacturing environments.
• Experience within highly regulated industries such as medical devices, electronics, automotive, aerospace, or industrial manufacturing is advantageous.
• Experience with ISO 13485, FDA Quality System Regulations, or similar quality management systems is considered a plus.

Please submit your English Version CV

If you find this role intriguing and possess several of the required experiences, we welcome your application. You might still be the ideal candidate for this position or other openings at Heartstream.

如果您符合以下条件，您将在这一岗位上取得成功：

• 您拥有工程学、电气工程、电子工程、供应链管理、制造工程、质量工程或相关专业的学士学位。
• 您具备**印刷电路板组装（PCBA，Printed Circuit Board Assembly）**相关工作经验。
• 您拥有供应商质量管理、制造质量管理、工艺工程、产品质量、供应商开发或新产品导入（NPI）等相关工作经验。
• 您熟悉以下质量管理工具和方法：
• 先进产品质量策划（APQP，Advanced Product Quality Planning）
• 生产件批准程序（PPAP，Production Part Approval Process）
• 过程失效模式与影响分析（PFMEA，Process Failure Mode and Effects Analysis）
• 测量系统分析（MSA，Measurement System Analysis）
• 统计过程控制（SPC，Statistical Process Control）
• 首件检验（FAI，First Article Inspection）
• 过程确认与验证（PV&V，Process Validation and Verification）
• 纠正与预防措施（CAPA，Corrective and Preventive Actions）
• 供应商质量管理体系（Supplier Quality Management Systems）
• 您能够熟练阅读和理解技术图纸、产品规范、制造工艺以及质量要求。
• 您具备优秀的问题分析与解决能力，能够运用数据分析识别根本原因，并制定有效的纠正措施。
• 您拥有出色的沟通和影响力，能够与供应商及跨职能团队建立良好的合作关系并有效推动工作开展。
• 鉴于英语是我们的全球业务沟通语言，我们希望您能够自信地进行英语听、说、读、写交流。
• 您具备持续改进的思维方式，并乐于在快节奏的产品开发和制造环境中工作。
• 具备医疗器械、电子制造、汽车、航空航天或工业制造等高度监管行业的工作经验者优先考虑。
• 具备 ISO 13485、FDA 质量体系法规（FDA Quality System Regulations） 或类似质量管理体系经验者将更具优势。

请提交您的英文版简历（English Version CV）。

如果您对这一职位感兴趣，并具备上述部分关键经验，我们诚挚欢迎您申请。即使您的背景并非完全符合所有要求，您仍有可能成为该职位或 Heartstream 其他职位的理想人选。