岗位职责:
1.Lead manage projects including new product development, transfer project process continuous improvement from concept to commercialization.
领导和管理项目,包括新产品开发,转移项目和从概念到商业化过程的持续改进。
2.Define project scope, milestones objectives to meet stakeholders requirement.
定义项目范围、里程碑和目标,以满足涉众的需求。
3.Develop detailed project plan, including project timeline, tooling breakdown, equipment breakdown, material breakdown, validation breakdown, sterilization stability breakdown regulatory activities.
制定详细的项目计划,包括项目时间表,工装,设备,材料,验证,灭菌和监管活动。
4.Develop monitrisk management plan to meet projects deliverables goals.
制定并监控风险管理计划,以满足项目的可交付成果和目标。
5.Lead work closely with cross-functional groups as well as outside group.
领导并与跨部门团队以及外部团队密切合作。
6.Responsible to establish product BOM monitproject expense within control
负责建立产品BOM并控制项目费用。
7.Conduction daily/weekly/monthly meeting with cross-functional to review projects status, discuss issues come out with solutions, project plan to track decision follow-up actions.
与各职能部门进行每日/每周/每月的会议,回顾项目状态,讨论问题并提出解决方案,更新项目计划,跟踪决策和后续行动。
8.Ensure all project required docs is ready before handover to production. Such as project file, design history file, PWI, inspection criteria, Forms procedures
确保所有项目所需文件在交付生产前准备就绪。如项目文件,设计历史文件,过程作业指导书,检验标准,表单和程序文件。
9.Lead validation activities prepare validation docs.
领导验证活动并准备验证文档。
10.Any other duties as assigned by the immediate superior.
上级交办的其他工作。
岗位要求:
1.Above college ,at least 5 years of experience in solving Injection molding issues
大专及以上学历,至少5年注塑问题解决经验。
2.Very familiar with molding of medical components which include IQ, OQ PQ validation processes。
非常熟悉医疗部件成型,包括IQ, OQ和PQ验证流程。
3.Understof plastic materials its relations to molding parameters
了解塑料材料及其与成型参数的关系。
4.Understtypes of plastic manufacturing solutions including 2k molding overmolding
了解各种塑料制造解决方案,包括2k模压和过度模压。
5.Familiar with type of molding machines
熟悉注塑机的类型
6.Experience in LSR molding LSR overmolding tooling construction of a LSR mold。
有LSR成型和LSR复模的经验,有LSR模具的模具构造经验。
7.Fluent in English listening, speaking, reading writing。
英语听说读写流利