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3D Systems Development Quality Engineer II - 2100000M in Littleton, Colorado

JOB SUMMARY:The 3D Systems site in Littleton, Colorado is expanding rapidly and needs askilled Quality Engineer to augment the Development Quality team under thedirection of the Quality Manager. The mission of the Development Quality teamis to ensure 3D System's products or services for new customers provide ahigh level of quality that meets expectations. Our pace of growth is onlymatched by the pace at which our customers expect their new and innovativeproducts to be delivered. This position will support the Customer InnovationCenter to incorporate customer-designed products into the 3D Systems contractmanufacturing portfolio, much like an OEM would develop internal productsthrough a product development process.Organization:As part of the Healthcare unit of 3D Systems, the Littleton facility acts asa service bureau to enable customers without the expertise, capital, ordesire to additively manufacture their products. We are experts in digitalworkflows, patient-specific devices, and five different kinds of 3Dprinting. The Quality department serves both the Virtual Surgical Planning aswell as the Contract Manufacturing product lines with plastic and metaladditive manufacturing.Performance Objectives:The following performance objectives will determine job success for thisposition:Develop Product Quality Processes: Utilize existing processes and inspectionmethods and augment capabilities with new processes to meet technicalrequirements of customer projects. Specify, justify financially,develop, and implement new methods for ensuring the quality of productproduced at 3D Systems. Participate in process validation as necessary.Perform Measurement System Analysis : Identify and evaluate measurementsystems to ensure accuracy, precision and stability used to assess productconformity.Resolve technical issues: Follow developed processes and projects throughdesign transfer and in to the first year of volume production. Working withina cross-functional team, ensure that insufficiently developed processes areremediated, work instructions are updated, and scrap is minimized.Document the results of investigation and resolution through the CAPA,NMR, or Deviation processes.Qualify New Suppliers : Evaluate new candidate suppliers to ensure they meetthe operational and quality needs of 3D Systems as governed by applicableregulatory bodies such as the FDA.Facilitate Design Transfer : Following internal procedures for product andprocess development, participate in the transfer of new projects intoManufacturing. Ensure that all required quality documentation is complete andreleased.Navigate Customer Requirements: Participate in customer project meetings andlead efforts to translate and understand part, project, and validationrequirements. Participate in complaint investigations, gather productconformity information, and coordinate with internal and externalstakeholders to optimize product quality.Create Device Master Records : Author work instructions in visual format forthe inspection and release of product. Implement all changes via the formaldocument control system.Perform Batch Release : Review device history records, ensure complianceto predetermined specifications, and generate product releasedocumentation, including certificates of analysis and conformity.Education and TrainingBS degree in engineering or related fieldExperience2-5 years of related work experience in regulated, cGMP environment such asmedical device, pharmaceutical or aerospace.Knowledge, Skills and AbilitiesQuality assurance and reliability experience supporting product developmentand/or manufacturing are preferred.Working knowledge of cGMP and ISO 13485 Quality SystemAbility to read and understand specifications across a number of products andmaterials.Ability to analyze and develop engineering processes for use in advancedtechnology implementations.Experience in preparing technical documentation.A successful candidate for this position will be a U.S. PersonCompensation and