Senior Manufacturing Engineer

Location(s)

Suzhou, Jiangsu

Company

Phillips Medisize

Career Field

Operations & Manufacturing

Job Number

193680

Your Job

• Responsible for developing robust, scalable, and compliant manufacturing solutions to support new product development, validation, and commercialization.

负责开发稳健、可扩展且符合质量及法规要求的制造解决方案，支持新产品开发、验证及商业化导入。

• Lead manufacturing development activities including process design, technical risk assessment, Process FMEA, equipment and fixture development, cost estimation, process validation, and design transfer.

主导制造开发工作，包括工艺设计、技术风险评估、P-FMEA、设备与工装开发、成本评估、工艺验证及设计转移。

• Ensure product designs are manufacturable, and manufacturing processes consistently meet quality, regulatory, cost, and delivery objectives.

确保产品设计具备良好的可制造性，并持续满足质量、法规、成本及交付目标。

• Support the company and its affiliates in Suzhou.

协助本公司在苏州关联公司。

What You Will Do

1. Lead the development of manufacturing strategies, process concepts, process flows, and industrialization plans for new products.

主导新产品制造策略、工艺概念、工艺流程及工业化计划的制定。

1. Support RFQ and project proposal activities by developing manufacturing concepts, preliminary process flows, equipment strategies, investment estimates, cycle-time assumptions, capacity assessments, and industrialization schedules.

支持RFQ及项目提案，制定制造概念、初步工艺流程、设备策略、投资预算、周期时间假设、产能评估及工业化计划。

1. Effectively cooperate with product designers to conduct DFA and manufacturing feasibility reviews and provide actionable design improvement recommendations to optimize product design, develop the assembly line and process to meet production requirement.

与产品设计人员有效配合，在产品设计阶段开展DFA及制造可行性评审，并提出可执行的设计优化建议，开发满足生产要求的装配线和工艺。

1. Evaluate manual, semi-automated, and automated manufacturing solutions based on product maturity, quality requirements, production volume, cost, and scalability. Develop robust and scalable assembly, secondary, in-line inspection, testing, and packaging processes from prototype and clinical builds through pilot and commercial production.

根据产品成熟度、质量要求、生产需求数量、成本及可扩展性，评估手动、半自动及自动化制造方案。开发稳健且可扩展的装配、二次加工、在线检验、测试及包装工艺，支持从原型和临床样品到试生产及商业化量产的不同阶段。

1. According to product drawings, specifications and requirements, develop user requirements and technical specifications for secondary process equipment, assembly equipment, fixtures etc. Lead equipment and fixture concept reviews, design reviews, supplier technical evaluations, risk reviews, progress monitoring, debugging, technical problem solving and acceptance activities.

根据产品图纸、规范和要求，开发制定二次加工设备、装配设备、治具等相关设备夹具的用户需求和技术规格。主导设备及治具的概念评审、设计评审、供应商技术评估、风险评审、进度跟进、调试、技术问题解决及验收活动。

1. Conduct technical and manufacturing risk assessments throughout product and process development. Translate relevant product design risks and critical product requirements into manufacturing process risks, process controls, inspection methods, equipment requirements, and validation activities.

在产品及制造工艺开发全过程中开展技术风险和制造风险评估。将相关产品设计风险和关键产品要求转化为制造过程风险、工艺控制、检验方法、设备要求及验证活动。

1. Develop process development and validation strategies based on process risk, product requirements, and applicable quality system requirements.

Cooperate with Quality and project teams plan and execute FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), equipment qualification and manufacturing process validation activities, including IQ, OQ, and PQ. Analyze validation results, deviations, and process performance data, and implement corrective actions when acceptance criteria are not achieved.

根据工艺风险、产品要求及适用的质量体系要求，制定工艺开发和验证策略。与质量和项目团队合作策划并执行组装设备确认，工厂验收测试、现场验收测试、设备确认和制造过程验证活动，包括IQ、OQ和PQ。分析验证结果、偏差及工艺表现数据，并在未达到验收标准时制定和实施纠正措施。

1. Provide manufacturing support during prototype, engineering, verification, clinical, pilot, and initial production builds.

为原型、工程样品、设计验证、临床样品、试生产及初期量产提供制造工程支持。

1. Lead or support manufacturing readiness reviews and design transfer activities, ensuring that processes, equipment, documentation, training, materials, quality controls, and production resources are ready before transfer to Operations.

主导或支持制造准备度评审和设计转移，确保工艺、设备、文件、培训、材料、质量控制及生产资源在转移至运营前准备就绪。

1. Lead structured problem-solving and root cause investigations for manufacturing and assembly related issues.

主导制造及组装相关问题的结构化问题解决和根因调查。

1. Continuous process improvement, improving work methods and processes. Capture and share lessons learned, manufacturing standards, technical knowledge, and best practices across projects and manufacturing sites.

持续过程改进，改进工作方法和流程。在不同项目及制造工厂之间总结并分享经验教训、制造标准、技术知识及最佳实践。

1. Prepare, review, and maintain manufacturing documentation, including process specifications, work instructions, equipment specifications, process flows, P-FMEAs, control plans, validation protocols and reports, and design transfer documentation. Ensure manufacturing documentation is accurate, approved, released, and implemented according to project plans and quality system requirements.

编制、评审并维护制造文件，包括工艺规范、作业指导书、设备规格、工艺流程、P-FMEA、控制计划、验证方案和报告及设计转移文件。确保制造文件准确，并按照项目计划及质量体系要求完成批准、发布和实施。

1. Other tasks assigned by Supervisor.

主管分配的其他工作。

1. Follow EHS related laws, regulations and company's EHS related management regulations, timely report potential risk, and propose safety improvement suggestions; For management position, be responsible for EHS management of the department/team.

遵守环境和职业健康安全相关法律法规，遵守公司环境和职业健康安全相关管理规定，及时上报身边安全隐患，并提出安全改进建议；若为管理岗位，需负责本部门、团队的环境和职业健康安全管理。

Who You Are (Basic Qualifications)

• Education学历 Required必需：Collage, major in Engineering or related

工程类大专

Preferred优先：Bachelor, major in Engineering or related

工程类学士

• Skills & Abilities技能 Required必需：

• Strong knowledge of manufacturing process development

熟悉制造工艺开发

• Strong knowledge of assembly processes, secondary processes, fixtures, manufacturing equipment, inspection methods, and packaging processes

• 熟悉装配工艺、二次加工、治具、制造设备、检验方法及包装工艺

• Strong knowledge and hands-on experience in Design for Manufacturability (DFM) and Design for Assembly (DFA), manufacturing feasibility assessment, process flow development,

具备丰富的 DFM（可制造性设计）、DFA（可装配性设计）、制造可行性评估和工艺流程开发经验

• Knowledge and Experience in risk management according to ISO 14971

具备 ISO 14971 风险管理知识和经验

• Knowledge of Lean manufacturing and continuous improvement methodologies

熟悉精益生产及持续改进方法

• Fluent in written and spoken English, and good communication skills.

具备良好的英语听说读写能力和良好的沟通能力

• Familiar with office software (Windows, MS Office, AutoCAD, 3D)

熟悉办公软件（Windows、MS Office、AutoCAD、3D）

Preferred优先：

• Strong analytical, problem-solving, and communication skills.

具备优秀的分析、解决问题及沟通能力。

• Experience in Medical Validations

医疗验证经验

• Experience工作经验 Required必需：

• 10+ years in manufacturing industry; Good knowledge of Electrical or Mechanical design software; Be familiar with mechanical design, assembly process and has automation equipment development experience.

10年以上制造行业经验；熟悉电气或机械设计软件；熟悉机械设计和装配工艺以及丰富的自动化设备开发经验。

What Will Put You Ahead

• Knowledge from the Medical industry 医疗行业背景优先

• Experience working in a global cross-functional environment 具有全球跨职能团队合作经验

• Team management 团队管理经验

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug

delivery systems, medical devices and diagnostic tools that save and improve the quality of life for

millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the

world, we share our customers’ mindset that every product is critical to a healthcare provider and their

patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc.,

one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.