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Open nowPosted 11 days ago

工艺工程师

op6e7e0f5e/social_recruitment14 open roles

Where
Suzhou, Jiangsu, Chinese Mainland
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Your applicationOpen now工艺工程师op6e7e0f5e/social_recruitment · Suzhou, Jiangsu, Chinese Mainland

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on op6e7e0f5e/social_recruitment's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 11 days ago

The posting

岗位职责（Job Description） 1. 负责新产品的工艺开发和制造流程设计，规划并建立对应的生产线； 2. 协助产品开发初期的可制造性DFM、可装配性DFA评估，能给予开发人员合理指导或可行性建议； 3. 主导新产品导入，开展设计开发到生产的转换，完成生产制造所需的工装治具开发、工艺过程验证和确认、样品试制等，确保设计开发输出得到验证并适用于商业化生产； 4. 负责对应产品线制造过程良率的提升，生产过程问题的收集与解决，以持续改善提升产品质量和制造效率； 5. 负责建立并维护对应产品线的工艺制程文件，如Flow Chart, MBOM, SOP, PFMEA, 批记录模板等； 6. 负责或协助进程产品失效的根因分析，并制定有效改善措施； 7. 工作地点：苏州科技城

任职要求（Basic Requirements） 1. 本科学历及以上，机电、自动化、材料、制造等理工类相关专业； 2. 5到10年医疗器械行业相关工作经验，至少3年三类无菌产品或植介入类器械工艺工程相关经验，能力佳者，可放宽工作年限要求； 3. 了解ISO13485、NMPA、FDA、MDR相关医疗器械法规要求，了解医疗器械产品开发流程，熟悉法规对设计开发转换和工艺制程的要求； 4. 能够根据产品设计和功能要求，基于过程PFMEA或其他风险分析工具输出，规划并建立生产制程，识别关键工序和特殊过程，并进行科学合理的验证确认； 5. 熟悉无菌医疗器械产品生产过程特点，对产品和原材料清洗干燥工艺、粘接与固化工艺、无菌包装封口工艺、标签打印工艺、以及精密组装工艺等有丰富经验； 6. 能够进行生产制造中工装治具的设计与优化，了解公差与配合关系； 7. 了解常见物料生产工艺，如精密机加工、注塑、挤出、粘接等； 8. 具备良好的数据分析能力，能够运用不同的工具和统计方法对生产检验的日常运行数据、测试验证数据等进行分析，发现问题并推动内部改善； 9. 良好的沟通表达能力，能够进行跨部门沟通与协调。

优先能力（Preferred Capabilities） 1. 熟练使用solidworks制图软件

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