MVE Biological Solutions is a major supplier to the life sciences industry of cryogenic solutions, providing freezers, dewars, related ancillary equipment and services used in the storage and transport of life sciences commodities, which include cell and gene therapies. Headquartered in Ball Ground, Georgia and with plants in New Prague, Minnesota and Chengdu, China and with over 226 dedicated employees, MVE serves over 300 customers. Like Cryoport Systems, Cryogene and CRYOPDP, MVE operates as a separate business unit of Cryoport, Inc. POSITION SUMMARY The Manufacturing Engineer provides support and solutions by leveraging general knowledge of manufacturing processes to increase plant efficiencies and meet, or exceed, goals related to safety, quality and production. Position is based in our Chengdu manufacturing facility and will be expected to support the NPD, product transfer and sustaining engineering projects. PRIMARY RESPONSIBILITIES (include but are not limited to) - Partner with the design engineering and commercial groups to support the NPD /product transfer projects at all stages (planning, input, mold development, output, review, process/product verification and validation, trial production, design transfer, engineering changes, etc.); - Responsible for test method/protocol development, prototype building, production line validation, PFEMA analysis, tooling/fixture design, parts localization, SOP/flowchart and other technical documents to compliance of procedure and regulatory for NPD and product transfer projects; - Plan, organize and implement systems and procedures for aiding in the manufacturing of MVE products while adhering to and promoting safety and quality guidelines - Personally conduct and/or supervise studies to determine cause, effect and the corrective measures required to remedy deviations impairing desirable standards of quality - Monitor production processes and then work with production personnel to create standard work procedures, enhance flow, and implement Lean concepts (e.g. 5S, Visual Work, Kanban) throughout the plant - Identify product assembly issues and initiate a strategy to resolve issues and improve product consistency and eliminate variance through effectively working with production, engineering and maintenance departments - Work closely with team members to identify and eliminate waste activities - Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency - Develop and perform qualification and validation procedures for newly introduced equipment and processes - Interface with various departments in defining and providing solutions to detected manufacturing processes causing quality problems - Identify, recommend, and justify opportunities for capital equipment improvements - Project Management of capital equipment projects, and ensuring on time delivery, managing budgetary constraints, and ROI - Provide supports to regulatory team for medical device registrations like MDD/MDR, FDA, CFDA within responsible area on the engineering aspects. - Has a basic understanding of the importance of IP for the MVE business, contributes to IP protection and develops IP documents. - Other duties and responsibilities as assigned by management - Observe and practice safety procedures and policies COMPETENCIES & PERSONAL ATTRIBUTES - Must possess a working knowledge of computers, including MS Word, Excel, AutoCAD, and SolidWorks - General familiarity of medical device or similar quality systems requirements - Knowledge of mechanical & electrical fundamentals including structural, GD&T, fluid flow, heat transfer, controller, solenoid valve or other electronics. - Understanding of MIG/TIG welding practices, sheet metal fabrication, Epoxy resin tubes fabrication, cryogenics, vacuum systems, and assembly, a plus - Understanding of factory metrics, Lean (Operational Excellence) and Six Sigma, a plus - Knowledge and understanding of company safety procedures and policies - Awareness and understanding of company quality standards, capital equipment, procurement, FMEA, APQP, ISO 13485, ISO 14971, ISO 14001, MDD/MDR - Effective communication, open minded, responsibility, teamwork sense and cross functional collaboration - Passion for, and alignment with, Cryoport’s mission, vision, values & operating principles. - Flexibility/stress handling, attention to detail and self motivation - Exceptional organizational and planning skills, strong analytical abilities, and process orientation QUALIFICATIONS AND EDUCATION REQUIREMENTS - BS degree or above in Engineering, preferably Manufacturing, Mechanical or Industrial - Prefer at least 3 years of experience in medical device manufacturing or related field, master fresh graduates would be considered - Fluent English both oral and written, CET-4 (CET-6 preferred) or equivalent certification
