Senior Mechanical Engineer

Position Name职位

Senior Mechanical Engineer高级机械设计工程师

Department部门

Refer to myHR

JD Revise date 修订日期

12.Aug.2026

Primary Purpose

职位设置目的

·Responsible for the design, development, verification, and industrialization support of medical devices and drug delivery systems. Will lead mechanical engineering activities throughout the product development lifecycle from concept generation through design verification, validation, and manufacturing transfer while ensuring compliance with medical device regulatory requirements and design control processes.

负责医疗器械及药物递送系统产品的机械设计、开发、验证及产业化支持工作。将主导产品从概念开发到量产导入全过程中的机械工程活动，并确保符合医疗器械法规及设计控制要求。

·Support the company and its affiliates in Suzhou.

协助本公司在苏州关联公司。

Duties & Responsibilities

工作职责

1. Lead mechanical design and development of medical devices and drug delivery products etc., and design optimization activities.

产品设计与开发过程中主导医疗器械及药物递送产品等的机械设计与开发以及设计优化活动。

2. Develop innovative design concepts and transform them into manufacturable products.

开发创新产品方案并实现工程化落地。

3. Create detailed 3D and 2D engineering drawings, and specifications.

完成3D、工程图纸及技术规范编制。

4. Conduct design reviews and technical risk assessments.

组织设计评审与技术风险分析。

5. Follow ISO 13485 Design Control processes throughout product development.

按照ISO13485设计控制要求开展产品开发。

6. Perform risk assessments in accordance with ISO 14971.

根据ISO14971开展产品风险管理活动。

7. Develop and maintain:

• Design Inputs
• Design Outputs
• Verification Plans
• Validation Plans
• Design History File (DHF)

建立并维护：

• 设计输入
• 设计输出
• 验证方案
• 确认方案
• 设计历史文件（DHF）

8. Perform tolerance stack-up analysis and GD&T evaluations.

开展尺寸链分析及GD&T设计。

9. Conduct engineering calculations and simulations as needed.

进行工程计算及仿真分析如需要。

10. Support Engineering Confidence Testing, Design Verification and Design Validation.

支持工程测试、设计验证以及设计确认活动。

11. Analyze engineering data and drive design improvements.

分析试验数据并推动产品优化。

12．Support statistical analysis and design robustness studies.

支持统计分析及设计稳健性研究。

13. Collaborate with Manufacturing and Quality teams to ensure successful product design transfer.

与制造及质量团队协作完成产品设计转移。

14. Support DFM, DFA, and Design Transfer activities.

支持DFM、DFA及设计转移工作。

15. Support problem solving and root cause investigations activities.

参与相关的问题解决和根本原因分析活动。

16. Other tasks assigned by Supervisor.

主管分配的其他工作。

17. 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。

Scope/范围

Location地点： Suzhou 苏州

Reports to汇报对象

Refer to myHR

Supervises管理对象

NA

Contacts沟通与联络

Internal & external customers and suppliers, Design Engineers, Quality Engineers, Project Managers, Manufacturing Engineers, Tooling Engineers, Process Engineer etc.

内外部客户和供应商、设计开发工程师、质量工程师、项目经理、生产、制造工程师、模具工程师、工艺工程师等。

Function Demands

岗位要求

·Education学历

Required必需：College and Bachelor's degree in Mechanical Design and Mechatronics Engineering or related Engineering disciplines.

机械设计以及机电一体化等相关工程专业大专和本科学历。

Preferred优先：Bachelor or above, major in Mechanical Design.

机械设计类本科及以上。

·Skills & Abilities技能

Required必需：

•Strong experience in mechanical system and mechanism design.

具备扎实的机械系统及机构设计能力。

•Proficient in NX, SolidWorks, or Creo for 3D modeling and development of detailed engineering drawings, specifications, and technical documentation in compliance with GD&T and applicable design standards.

熟练使用 NX、SolidWorks 或 Creo 等设计软件进行三维建模，并能够独立完成符合 GD&T 及相关设计标准要求的工程图纸、技术规范和技术文件编制。

•Strong knowledge of medical device product development processes and Design Controls under ISO 13485.

熟悉医疗器械产品开发流程及 ISO 13485 设计控制要求。

•Strong knowledge of tolerance stack-up analysis and GD&T.

熟悉尺寸链分析及 GD&T（几何尺寸与公差）。

•Familiar with tooling development, injection molding processes, and manufacturing assembly processes.

熟悉模具开发、注塑成型工艺及产品装配制造工艺。

•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。

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。

•Knowledge and experience in design verification, validation, and root cause analysis.

具备产品验证、确认及问题根因分析知识和经验。

•Strong knowledge and hands-on experience in Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Testing (DFT).

具备丰富的 DFM（可制造性设计）、DFA（可装配性设计）及 DFT（可测试性设计）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。

·Experience工作经验

Required必需：

•10+ years of Product Mechanical Design experience;

10年以上产品机械设计行业经验；

•Minimum 5 years in Medical Device, Drug Delivery, Diagnostic Device, Life Science, or similar regulated industries.

至少5年以上医疗器械、药物递送、诊断设备或相关受监管行业经验。

Preferred优先：

•Experience in drug delivery systems, inhalation devices, nasal spray systems, auto-injectors, or wearable medical devices etc.

具有药物递送系统、吸入器、鼻喷装置、自动注射器或可穿戴医疗器械等开发经验。

•Diverse product portfolio experience.

多元化产品组合经验。

•Experience working under Design Controls and Quality Management Systems.

具有设计控制及质量体系环境下工作经验。

•Strong understanding of tooling development, injection molding, assembly processes, DFM/DFA, and design transfer into regulated manufacturing industries.

深入理解模具开发、注塑成型、装配工艺、DFM/DFA原则以及受监管医疗器械制行业的设计转移过程。

•Experience working in a global cross-functional environment.

具有全球跨职能团队合作经验。