南京招聘

Essential Responsibilities :? Manage the working partnerships with outside resources for the concept/product development, contract manufacturing, and testing of devices when applicable.? Interface directly with customers and internal groups to resolve customer complaint investigations, drive root cause analysis and implement quality and design related improvements. ? Identify, collaborate and manage outside suppliers on material selection, tool design, manufacturing technologies and specifications for components, sub assemblies, finished assemblies.? Address implementation complexity, risks, manufacturability, serviceability and quality.? Leads projects with cross-functional teams, create WBS and Gannt chart schedules.? Time schedule - Establishes project plan and delivers according to business needs.? Cost estimates - delivers according to budget; assists in the development of cost estimates for future projects.? Report – Routinely updates management and stakeholders with project status.? Contributes in the design of plastic components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability.? Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.? Collaborate closely with cross-functional departments worldwide – Marketing, Quality, Regulatory and Manufacturing to drive projects to completion.

Qualifications/Requirements :? Bachelor’s degree in either; Mechanical Engineering, Plastics Engineering, Bioengineering, Material Science, Microbiology or Chemistry.? 5 years of relevant experience in either; Bio-Processing, Biological Sciences, Biotechnology, medical device development or a related field.? Knowledge of plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.? Basic understanding of biocompatible materials, properties, manufacturing methods, processes, and product assembly of single-use devices.? Awareness of GMP and governmental regulations related to drug manufacturing. ? Familiarity with relevant regulatory (FDA, ISO) and Q/A guidelines governing implementation and use of disposable materials and components.? Strong communication and writing skills for working with global manufacturing, marketing, and development teams. Bilingual in English and Chinese (Mandarin).