Process Development Engineer
Surf Search - san diego, CA
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We are searching for a Process Development Engineer for a rapidly growing medical devices company. This exciting company, in the cardiovascular space, is expected to go public next year. It has several diagnostic platforms in development.The Process Development Engineer will work to design, develop, and implement, new and improved manufacturing processes for the company's control console program. The Process Development Engineer will provide daily support of products, processes, materials and supplier management, and equipment for new and sustaining products.Requirements for the Process Development Engineer:Bachelor's Degree in engineering preferably mechanical or biomedical.3+ years' medical device experience in processmanufacturing engineering role.Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technologyprocess transfer experience, productprocess failure mode and effects analysis (FMEA), and problem solving methodologies.Experience with validationverification of processesinspection methods for manufacturing (IQ, OQ, PQ)Understanding of medical device design controls quality systems and product development processesExperience in a regulated environment; preferably medical deviceSolid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.Excellent verbalwritten communication skillsAbility to organize, records, and implement proceduresSix Sigma training, certification preferredExperienced in CAD, preferably SolidWorksOccupational Category: 17-2141 Mechanical Engineers
Created: 2024-10-03