Sr. Process Engineer

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

• 主导新设备和新工艺的设计、导入、制造跟进、验收及验证，确保项目满足质量、成本和进度目标。
  Lead the design, introduction, build follow-up, acceptance, and validation of new equipment and processes, ensuring project quality, cost, and schedule objectives are met.
• 依据工程变更流程持续优化现有生产工艺，推动效率、质量和稳定性提升。
  Continuously improve existing manufacturing processes through the engineering change process to enhance efficiency, quality, and process robustness.
• 按照公司项目管理流程独立推进项目，制定项目计划和里程碑，协调跨职能资源，跟踪风险与行动项，并定期汇报项目状态。
  Manage projects independently in accordance with company project-management procedures by defining plans and milestones, coordinating cross-functional resources, tracking risks and actions, and reporting project status regularly.
• 维护工程相关受控文件，包括产品规范、PFMEA及工艺和验证文件。
  Maintain engineering-controlled documents, including product specifications, PFMEAs, and process and validation documentation.
• 负责或协助准备产品注册所需的工厂文件，并支持内外部审核。
  Prepare or support site documentation required for product registration and internal or external audits.
• 定期审核相关文件，确保持续符合法规、质量体系及审计要求。
  Periodically review relevant documentation to ensure ongoing compliance with regulatory, quality-system, and audit requirements.

• 完成直线经理安排的其他相关工作。
  Perform other related duties assigned by the line manager.

经验 & 学历EXPERIENCE & EDUCATION:

• 本科及以上学历，工业工程、高分子材料、机械工程、自动化或相关工程专业。
  Bachelor’s degree or above in Industrial Engineering, Polymer Materials, Mechanical Engineering, Automation, or a related engineering discipline.
• 至少3年医疗器械耗材的装配制造及包装相关经验。
  At least three years of experience in the assembly, manufacturing, and packaging of medical-device consumables.
• 熟悉ISO 13485质量管理体系者优先。
  Familiarity with the ISO 13485 quality management system is preferred.
• 熟悉医疗器械、制药或食品行业的洁净室生产；具备高速自动化装配线及过程验证经验者优先。
  Experience with cleanroom manufacturing in the medical-device, pharmaceutical, or food industry is preferred. Experience with high-speed automated assembly lines and process validation is an advantage.

技能KNOWLEDGE, SKILLS AND ABILITIES:

• 熟悉产品装配和制造工艺。
  Strong knowledge of product assembly and manufacturing processes.
• 熟悉PFMEA、DOE、工艺开发及过程验证。
  Proficiency in PFMEA, DOE, process development, and process validation.
• 具备新产品导入（NPI）及先进制造工程项目经验。
  Experience in New Product Introduction (NPI) and advanced manufacturing engineering projects.
• 具备开发新工艺和新技术、提升生产效率与过程能力的能力。
  Ability to develop new processes and technologies that improve production efficiency and process capability.
• 具备良好的项目管理、跨职能沟通、组织协调和问题解决能力。
  Strong project-management, cross-functional communication, coordination, and problem-solving skills.
• 具备良好的中英文沟通及书面表达能力。
  Good verbal and written communication skills in both Chinese and English.

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embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.