Full - Stack Developer enhancing conversational AI products used by sales teams. Working student role in a scaling startup environment, with potential transition to full - time.
About the role
- Senior Process Engineer responsible for enhancing manufacturing operations in medical device industry. Leading process capability improvements and mentoring technical staff on production floor.
Responsibilities
- 促进所有生产区域、设备、流程和程序的安全第一思维
- 为指定活动和最佳实践提供指导和日常方向
- 在制造执行过程中利用精益流程技术和自动化，持续改善制造环境，推动成本领先、世界级质量和客户满意度
- 与新产品引入团队协作，确保新工艺流程的无缝实施并协助转移工作
- 高效完成项目，报告状态，记录经验教训；利用项目管理工具建立时间表、行动事项列表、分配、截止日期和里程碑
- 领导过程验证活动，包括设备、工具和流程的 IQ、OQ 和 PQ
- 开发/改进满足客户在成本、质量和交付方面期望的流程和抽样活动，以及工具和制造概念
- 通过应用精益原则，领导过程改进和消除浪费的工作；积极参与持续改进活动
- 进行 DOE 研究、过程表征和根本原因分析，以建立和维护稳健的过程窗口
- 可能会与现有客户沟通现有流程的变更，传达时间表，并管理与变更相关的验证活动
- 应用统计工具建立/监控能力并验证改进的有效性
- 领导调查并推动 NCR/MRB/CAPA 行动的关闭，与质量和运营部门合作；通过变更控制执行已批准的变更
- 展示所有企业价值观，我们以业主的身份思考和行动。我们在追求目标时果敢，同时始终秉持谦逊和诚信。我们致力于使客户成功。我们培养积极向上的团队。
Requirements
- 工程学相关领域的学士学位
- 在医疗设备或合同医疗设备制造环境中拥有 5 年以上的工程经验
- 熟悉典型的医疗设备制造技术（打顶、热塑性注射成型和挤出）
- 精通 Microsoft Word、Excel、PowerPoint 和 Minitab（或其他统计分析软件）
- 具有领导 IQ/OQ/PQ 的经验，并能遵循 ISO 13485 / FDA 21 CFR 820
- 具备 DOE、SPC 及 Gage R&R 的实际经验 | 熟悉控制计划和 PFMEA
- 必须具有 Microsoft Word、Excel、PowerPoint 和 Minitab（或其他统计分析软件）方面的高级技能
- 熟练使用 SOLIDWORKS 或 CAD 建模软件者优先
- 具备分析和解决问题的能力；注重细节，能够制作准确、专业的文档
- 有积极主动和创造力；在快节奏的团队环境中有效运作
- 出色的人际交往能力，能够有效沟通需求和要求
- 通过精益原则推动持续改进和消除浪费。
Benefits
- 职业发展机会
- 健康保险
- 401(k) 计划
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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