Sr. Manufacturing Development Engineer (GCN, Reports to Director of Manufacturing Engineering) 高级制造开发工程师
• Principal Activities/Responsibilities 主要工作职责
o Perform risk assessments and manufacturing feasibility reviews for new products(对新产品进行风险及可制造性评估。)
o Work closely with manufacturing to develop best methods for cost effective and quality focused manufacturing with Lean Six sigma methodology. This includes tool, fixture and test equipment design as well as proper hand-off from Sample/Verification builds to Validation builds. (与生产紧密合作，利用精益六西格玛方法制定成本效益和质量为重点的最佳生产方案。这包括模具、工装夹具和测试设备的设计，以及从样品/验证阶段到确认阶段的适当转换。)
o Collaborate with Design Engineering to ensure design for manufacturability when developing new products (与设计工程合作，确保开发的新产品的可制造性。)
o Work with Validation Engineer to assist in the Master Validation Plan as well as coordinate and guide manufacturing in the verification & validation activities including IQ, OQ and PQ. This will include mechanical and electrical testing methods as well as report creation. (配合验证工程师协助制定主验证计划，并在验证和确认活动中协调和指导生产，包括IQ、OQ和PQ的运行。这将包括机械和电气测试方法以及生成报告。)
o Review engineering verification samples, documents and test reports for customer approval (审查工程验证样品、文件和测试报告给客户审批。)
o Provide manufacturing support for product modifications and/or extensions. (对产品的改良及升级提供制造支持)
o Perform root cause analysis and review of internal and field failures. (对内部和现场故障进行根本原因分析和审查)
o Respond to customer complaints on manufacturing related issues. (回应客户与生产制造有关的问题投诉。)
• Job Requirements (岗位要求)
o University Degree in Mechanical or Mechanical & Electrical or Industrial/Manufacturing Engineering or equivalent is required. (大学本科学历，机械，机电或工业工程专业或相关专业。)
o Medical device manufacturing is required, background in Medical cable and connector assemblies/accessories is preferred but not a requirement. (有医疗器械制造行业经验，有医疗电缆和连接器组件/附件的背景优先考虑。)
o Electro-mechanical engineering experience. (机电工程经验)
o 5 years min. engineering experience. (至少5年工程从业经验)
o Lean Six-Sigma experience is preferred. (有精益六西格玛经验更佳。)
o AutoCAD experience. (会使用CAD软件。)
o Experience in 3D CAD modeling (Preferably SolidWorks) is a plus. (有3D 软件建模(最好是SolidWorks) 经验优先。)
o English reading and writing, listening and speaking is preferred but not a requirement. (具有英语读、写能力，有听、说能力更佳。)
o Experience in product Verification and Validation testing and report creation is a requirement. (具有产品验证和确认测试以及生成报告的经验。)
o Self-motivated and proactive. (自我激励，积极主动。)
o Experience working under ISO 13485. (有在ISO13485体系工作经验。)
o Understanding of assessing risks and risk mitigation, manufacturing engineering processes, tooling, plastic molding as well as metal machining and stamping techniques. (了解评估风险和降低风险、生产工程流程、工装、塑胶模具以及五金加工和冲压技术。)
o Must possess cross functional skills to communicate with other team members. (具备跨职能团队的沟通技能。)
5923 3309-|171 6442 9963 64o Have an attitude of collaboration with other engineers, manufacturing partners and a willingness to brainstorm ideas. (具有与其他工程师、生产合作伙伴协同合作的心态以及乐意参与集思广益。)