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3D Systems Process/Validation Engineer - 2100005D in Littleton, Colorado

Organization:3D Systems Littleton, is a dynamic and leading enterprise, specialized in3D Printing of metal and other material components. 3D Systems Littleton isnot only a technology developer but also a technology user. This makes us astrong innovation partner for clients in the aerospace, industrial,medical and dental sectors.JOB DESCRIPTION:The 3D Systems site in Littleton, Colorado is expanding rapidly and needs askilled Validation/Process Engineer as part of the Application InnovationGroup. This role will be within the Application Innovation Group (AIG)under the direction of the Senior Validation Engineer. The mission of the teamis to accelerate the development of advanced applications and innovativeadditive manufacturing solutions, for 3DS, for their clients and thesociety as a whole. We pull from technology, software, materials andservice to offer unmatched solutions to our customers. Our pace of growth isonly matched by the pace at which our customers expect their new andinnovative products to be delivered.The Validation Support Engineer is responsible for focusing interfacing withcustomers to help facilitate the implementation of process controls andvalidations as regulated by the ISO 13485, ISO 9001, AS9100 and globalrequirements such as FDA QSR, MDD and various aerospace regulations. Thisposition is responsible for supporting the development and execution ofmanufacturing processes and quality systems in accordance with internalguidelines as well as customer driven requirements.In this job, you will not only cooperate with your manufacturing, qualityand application engineering colleagues world-wide but you can also rely on theknowledge and experience of colleagues from other 3D Systems divisions.You are capable of assessing customer demand. Using a project managementapproach you define and deliver your projects in time and within budget. Youwill work closely with the Project Management Office collegues and AIGmanagement to allocate resources, engage with customers and set internalteams up for successPerformance Objectives:The following performance objectives will determine job success for thisposition:Collaboration with project teams, including both internal and externalstakeholders, as a contributing member by providing quality and processengineering support in the development of new products and processes using 3DSystems' products.Application and process development of new technologies to enhance thecapabilities of 3D Systems'Contributing to the development and execution of verification and validationplans, testing, and generation of test protocols and reportsDetailed project assessment and project planning inclusive of gains,investments, resources, and timing.Project leadership of initiatives across cross-functional teamsDevelopment of 3D printing processesCoordination and execution of process qualifications inclusive of IQ, OQ,and PQ.Development and contribution to the risk management processDevelopment and contribution of process controls and planningParticipating in the compilation and review of technical documentation forboth domestic and international regulatory submissionsAssisting project teams on compliance with design control requirements per FDAQSR, European MDD, ISO 13485/9001 and other applicable ISO/EN standardsParticipating in the execution, maintenance and improvement of the QualityManagement System.This document represents the major duties, responsibilities, andauthorities of this job, and is not intended to be a complete list of alltasks and functions. It should be understood, therefore, that incumbentsmay be asked to perform job-related duties beyond those explicitly described.Compensation and BenefitsSalary Range: $67,900 - 95,100 (Salary to be determined by theeducation, experience, knowledge, skills, and abilities of thecandidate, and alignment with market data)In addition to a salary, this position is eligible for an annual bonus basedupon company performance.3D Systems offers a comprehensiv

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