KEY RESPONSIBILITIES / DUTIES主要职责:

• The primary objective of this position is to work on the new product introduction projects to achieve excellent quality, delivery and cost goals.

该职位的主要目的在于推进新产品导入项目,以实现高质量, 及其交付和成本目标.

• Work with the divisional R&D team, Advanced Operations team of other Stryker Sites, and local site team to lead or support on the execution of new product introduction project tasks.

与研发团队和其他史赛克工厂的先期运营团队以及当地团队合作,引导或支持新产品导入项目任务的执行.

·       Will aid in the new product development process, from concept to launch, by identifying effective and efficient assembly techniques and manufacturing processes to be used.

从设计概念直至产品发布，通过识别使用的有效和高效的制造工艺和装配技术，协助新产品开发工艺。

·       Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.

设计和/或执行用于检验、测试及评估产品和/或生产和/或测试设备的准确性和可靠性的方法和程序。

• Analyzes reports and/or returned products and recommends corrective action.

分析报告和/或回流产品，并推荐纠正措施。

·       Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product design transfers and launches.

参与设计转移与产品量产发布相关的 PFMEA、控制计划、SOP 作业指导书以及 PPAP 等文件编制。

·       Ensure adherence to GMP and safety procedures.

确保严格遵守GMP规范和安全作业流程。

·       Develop and execute process and product protocol.

开发和执行工艺和产品协议。

·       Develop statistical process controls and analyze data.  Optimize operating parameters.

发展统计过程控制和分析数据，优化操作参数。

·       Lead, monitor and control progress of projects to ensure sound application of engineering principles used, and design intent is being achieved.

引导、监控和控制项目进展，确保合理使用工程原理，且设计目标得以实现。

·       Work with Manufacturing Engineer for equipment acquisition activity from specifying equipment, contract negotiation, Installation and validation.

与制造工程师合作设备采购全流程工作，包含设备规格定义、合同谈判、设备安装以及验证。

·       Develop the Validation plan for new products and their manufacturing processes.

将对新产品及其制造工艺开发新的验证计划。

·       Plan and execute process validation protocols including IQ, OQ and PQ.

计划并执行包含IQ，OQ，PQ在内的工艺验证协议。

·       Ensure manufacturing documentation and process validation are complete, accurate and within QMS compliance.

确保制造文件和工艺验证完整、准确且符合QMS。

·       Perform engineering risk analysis to manage technical difficulties encountered with new medical devices.

进行工程风险分析，以处理新的医疗器械遇到的技术困难。

·       Participate and aid in the new product development process by identifying effective test methods.

通过识别有效测试方法，参与并协助新产品开发进程。

·       Lead the process development (flowchart, logistics, manufacturing sequence, etc.).

引导工艺开发（流程图，后勤，生产顺序等）

·       Develop manufacturing processes to increase manufacturing capabilities and lower operational costs.

开发制造工艺，以增加制造能力和降低操作成本。

·       Design, build and/or purchase fixtures, equipment, machines and tools as needed to ensure quality products at minimal costs.

按需要设计、创建和/或购买夹具、设备、机器和工装，确保高质量产品的最低成本。

·       Assist suppliers in resolving manufacturing and quality issues.

帮助供应商解决制造和质量问题。

·       Interface among multiple departments and teams including R&D, Manufacturing and Quality, vendors and senior managers to ensure specific cost, time and or regulatory standards are met.

与包括研发、制造、质量、供应商和高级管理人员在内的多个部门相配合，确保特定的生产时间和成本，和/或确保其符合法规标准。

·       All other duties as assigned

完成上级安排的其它工作

SUPERVISORY RESPONSIBILITIES管理职责:

N/A

REQUIRED SKILL SET岗位技能：

·       CNC machining knowledge, or other manufacturing knowledge.

CNC机械加工知识，或其他制造知识。

·       Blueprint/engineering schematic reading and interpretation

设计图/工程原理图的阅读和解释能力。

·       CNC programming capability is preferred.

优先考虑具有CNC编程能力的人。

·       Excellent written and oral communication skills

优秀的写作和口头沟通能力。

·       Excellent organizational, problem-solving, and analytical skills

优秀的组织、问题解决及分析能力。

·       Ability to manage priorities and workflow

管理优先顺序及工作流程的能力。

·       Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

通用性、灵活性并自愿充满热忱地处理不断改变的优先项。

·       Proficient on basic computer programs Excel, Word, PowerPoint

熟练掌握基础计算机程序，如Excel、Word、PowerPoint。

·       Proven ability to handle multiple projects and meet deadlines

具有处理多个项目并如期完成的能力。

·       Strong interpersonal skills.

较强的人际交往能力。

·       Ability to deal effectively with a diversity of individuals at all organizational levels.

能有效地与各个组织层次的不同个体打交道的能力。

·       Good judgment with the ability to make timely and sound decisions

良好的判断力，及做出及时且合理决定的能力。

·       Working knowledge of data collection, data analysis, evaluation, and scientific method.

数据收集、数据分析、评估和科学方法等应用知识。

·       Demonstrated problem solving skills

问题解决能力。

·       Must be able to speak, read, write, and understand the primary language(s) used in the workplace.

必须能够交流、阅读、书写及理解工作场所使用的主要语言。

·       Must be able to communicate product and/or component part deficiencies to engineering personnel, subordinate, or supervisory personnel.

必须能够就产品和/或零部件缺陷与工程人员、下级或监察人员沟通。

RELEVANT EXPERIENCE

经验要求：

·       At least 5+ years related experience, have Stryker working experience preferred

至少5年以上相关经验, 有史赛克工作经验者优先。

·       Experience in developing and working with small group problem solving teams.

与小组问题解决团队发展和工作的经验。

·       Experience in process development in medical device industry is preferred.

优先考虑有医疗器械行业工艺开发经验者。

·       Experience on process quality and quality assurance is preferred。

有工艺质量和质量保证方面经验者优先。

EDUCATION

教育背景：

·       B.S. in Engineering, or above is preferred.

工程学位学士或更高学历者优先。