长沙招聘

职位描述：
Role：
· Report to VP Manufacturing / Vice General Manager
· Manufacturing plant will be located in Shenzhen. Work in SuZhou for this year，then transfer to ShenZhen
· Manage prototype manufacturing, New Product Introduction (NPI) design transfer, mass production and supply chain in advanced ophthalmic diagnostic scopes
· Key leader to coordinate on-the-ground activity at the manufacturing site, as well as communicate status, issues, etc. to senior management
· In product development phases, provide leadership in early and on-going manufacturing involvement with development engineering and product marketing teams to ensure new products are designed for manufacturability and propose alternative manufacturing approaches
· In product prototype phases, lead evaluation, development, engineering/procurement of process technologies realization, assembly tools, manufacturing equipment, and suppliers to enable prototype build and prepare for pilot production
· In design transfer phase, drive equipment/material suppliers to develop reliable, high-throughput, mass production-capable equipment that delivers tightly controlled process performance that meets pre-defined specifications. Lead mass production capable process definition, Identify and select the best method for mass production
· In mass production phases, lead the roll-out of equipment, material, and process across supply chain, optimize the process and equipment for device performance, yield, quality, reliability, and throughput, and ramp the new equipment/process into full mass production. Facilitate efficient operations within the production area by constantly optimizing processes and ensuring that production goals are met
· Establish production quality assurance strategy and plan, and responsible for supplier quality control and production quality control execution
· Establish procurement and supply chain management strategies

Highlights of Accountability:
· (Influence/Leadership) Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives
· (Planning/Organization) Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget
· (Decision Making/Impact) Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds; without jeopardizing future business activity

Detailed Duties and Responsibilities：
· Represent operations on engineering, product marketing, and program management teams and facilitate crisis escalation
· Drive early and on-going operations involvement to ensure new products are designed for manufacturability and propose alternative manufacturing approaches
· Working with product marketing and engineering teams to embed and optimize best practices enabling more efficient operations and supply chain processes and value engineering improvements
· Develop NPI product value chain (make vs buy) and supply chain strategy.
· Drive cross-functional teams to develop launch FMEA risk assessment and proactively manages mitigation and contingency plans
· Lead the manufacturing for ISO13485 certification and FDA/CFDA compliance certification
· Recruit and mentor staff to grow the team’s capability and their individual talent
· Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
· Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports.
· Contributes to the development and monitoring of area budget through regular analysis of cost and spending
· Must be willing to travel within China as well as internationally (20%)

Required Skills：
· Demonstrated systems level leadership and strategic planning skills and the ability to communicate and influence across the organization
· Excellent problem solving skills, demonstrated critical thinking and use of statistical methods. Six Sigma certification desired
· Ability to promote change and innovation by developing creative manufacturing processes
· Knowledge of process validations, risk management, equipment
· Design for Manufacturability expert with a proven track record of delivering improvements in efficiency, quality and product launch predictability
· Firm understanding of GMP, quality system requirements, CAPA, and lean manufacturing tools
· Demonstrated ability to perform tolerance stack-up analyses, DOEs, SPC, data analysis, and failure analysis is a must.
· Familiarity and with failure analysis techniques such as FMEA, SEM, EDX, FTIR, etc is required
· Excellent written and verbal communication skills are required in both Mandarin and English

Required Experience：
· Bachelor’s degree in Mechanical Engineering, Physics, Materials Science & Engineering, Electrical Engineering, Precision and Optical Instruments, Biomedical Engineering, Chemistry/Chemical Engineering, or other similar field; advanced degree preferred
· 10 years’ hands-on experience in the design and development of manufacturing processes and/or equipment for new product introduction and sustaining engineering in high volume manufacturing in the medical device industry
· 5 years’ experience managing team of manufacturing engineers and assembly line supervisors: coaching, mentoring, 1-1s, and performance management
· Experience with ISO13485 and FDA 510(k) is highly valued 举报 分享

  
   深圳市新产业眼科新技术有限公司（“新产业眼科”）成立于2006年，是一家专注于眼科医用产品研发、销售、服务的国家高新技术企业，产品覆盖以白内障治疗为核心，并逐步拓展至青光眼、眼底治疗和眼视光等眼科专业领域。
   在白内障治疗领域，新产业眼科主要经营美国Lenstec品牌的全系列人工晶状体产品。该品牌生产基地位于巴巴多斯，系列中的等凸非球面产品HD、大光学面非球产品HDO、预装式HDPLI、区域折射SBL-3等均拥有专利，核心产品已在美国FDA成功获批注册。根据行业权威Market Scope统计报告显示，Lenstec为全球排名前十的人工晶状体生产商。
   新产业眼科总部设在深圳，全国各省级城市均设有区域营销中心，新产业眼科的销售及物流网络遍布全国，24小时内响应配送和技术培训需求，目前已服务于全国超过1300多家医疗机构。新产业眼科将持续致力于为中国眼科市场提供高性价比的优质产品，为人类眼健康的发展贡献我们的一份力量！