Engineer Teknis R & D 研发技术工程师

R&D Technical Engineer

Job Description

We are looking for an R&D Technical Engineer to support the research, development, design, improvement, and technical management of disposable medical device products.

The role will be responsible for supporting product development and improvement activities throughout the product lifecycle, working closely with Quality, Production, and Regulatory Affairs teams to ensure product quality, compliance, and effective implementation of technical requirements. Understanding of ISO 13485 and other ISO certification requirement will be a bonus point.

Key Responsibilities

1. Product Research & Development

• Manage and execute the development and design process of disposable medical device products in accordance with applicable regulatory and quality requirements.
• Participate in product development activities from concept, design, development, verification and validation through production implementation.
• Conduct product and process trials, testing, evaluation, and technical analysis.
• Identify, analyze, and resolve technical issues during product development and trial production.
• Evaluate materials, processing methods, production equipment, molds, and tooling related to product development.
• Prepare and maintain product development-related technical documentation.

2. Product Lifecycle Management

• Support the full lifecycle management of medical device products, from design and validation through production and post-market activities.
• Maintain product technical information and development records throughout the product lifecycle.
• Participate in product improvement and engineering change activities.
• Support product risk management and related technical activities.
• Follow up on technical issues and improvement actions throughout the product lifecycle.

3. Product Improvement & Technical Support

• Analyze and improve existing products and production processes to enhance product quality, process stability, and production efficiency.
• Understand and apply polymer/material processing characteristics in product development and process improvement.
• Provide basic technical support for relevant production equipment and processes.
• Conduct technical analysis and root cause investigation for product or process abnormalities.
• Provide technical support and solutions to Production and Quality teams.
• Support implementation and follow-up of technical improvement activities.

4. Cross-Functional Collaboration

• Work closely with Quality, Production, and Regulatory Affairs departments on product and process-related matters.
• Clearly explain technical concepts, analysis, and technical logic to non-technical stakeholders using accessible language.
• Coordinate cross-functional activities to ensure effective implementation of technical requirements.
• Support resolution of cross-functional issues, particularly when balancing production efficiency with product quality and regulatory requirements.

5. Technical Documentation

• Prepare, compile, review, and maintain professional technical documentation, including:

  • Product development documents
  • Technical reports
  • Verification and validation documents
  • Product risk management documents
  • Engineering change documents
  • Technical investigation and analysis reports
  • Relevant procedures and technical records

• Ensure technical documents are accurate, systematic, traceable, and properly maintained.

Qualifications

• Bachelor's degree or above in Engineering, Biomedical Engineering, Polymer, Chemical Engineering, or related disciplines.
• Strong cross-functional communication and coordination skills.
• Detail-oriented, systematic, and able to work under audit and regulatory pressure.
• Capable of working independently as well as collaboratively within a team.

---

研发技术工程师

岗位说明

我们正在招聘一名研发技术工程师，负责支持一次性医疗器械产品的研发、设计、改善及技术管理工作。

该职位将参与产品全生命周期相关的研发及改善工作，并与质量、生产及法规事务部门密切合作，确保产品质量、法规符合性及技术要求得到有效落实。

主要工作职责

1. 产品研发

• 根据相关法规及质量要求，负责一次性医疗器械产品的研发与设计流程。
• 参与产品从概念、设计、开发、验证与确认到生产实施的相关工作。
• 负责产品及工艺试验、测试、评估及技术分析。
• 识别、分析并解决产品开发及试生产过程中出现的技术问题。
• 评估产品开发相关的材料、加工方式、生产设备、模具及工装。
• 编制、整理及维护产品开发相关技术文件。

2. 产品全生命周期管理

• 负责支持医疗器械产品的全生命周期管理，从设计、验证到生产及上市后相关活动。
• 维护产品全生命周期中的技术资料及开发记录。
• 参与产品改善及工程变更相关工作。
• 参与产品风险管理及相关技术活动。
• 跟进产品全生命周期中的技术问题及改善措施。

3. 产品改善及技术支持

• 分析及改善现有产品和生产工艺，以提升产品质量、工艺稳定性及生产效率。
• 了解并应用高分子材料/材料加工特性于产品开发及工艺改善。
• 为相关生产设备及工艺提供基本技术支持。
• 针对产品或工艺异常进行技术分析及根本原因调查。
• 为生产及质量部门提供技术支持及解决方案。
• 支持技术改善措施的实施及跟进。

4. 跨部门协作

• 与质量、生产及法规事务部门密切合作，处理产品及工艺相关事项。
• 能够以易于理解的语言向非技术人员清晰说明技术概念、分析结果及技术逻辑。
• 协调跨部门工作，确保技术要求得到有效落实。
• 协助解决跨部门问题，特别是在生产效率、产品质量及法规要求之间进行协调。

5. 技术文件管理

• 负责编制、整理、审核及维护专业技术文件，包括：

  • 产品开发文件
  • 技术报告
  • 验证与确认文件
  • 产品风险管理文件
  • 工程变更文件
  • 技术调查及分析报告
  • 相关程序及技术记录

• 确保技术文件准确、系统、可追溯并得到妥善维护。

任职资格

• 工程、生物医学工程、高分子、化学工程或相关专业本科及以上学历。
• 具备良好的跨部门沟通与协调能力。
• 工作严谨细致、思路清晰，能够适应审核及法规相关工作压力。
• 具备独立工作能力，同时能够良好地进行团队合作。