Development Quality Engineer III

Company: 3D Systems
Location: Littleton
Posted on: May 26, 2023

Job Description:

Who We Are: /More than 30 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction - empowering our customers to create products and business models never before possible. 3D Systems' solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods./ What We Value: Our values are the heart of our culture. They represent our identity, and they are our guideposts for everything we do. They articulate what we do to achieve meaningful results and make a difference for our customers, stakeholders, and each other. * Grow Profitability and Win * Deliver "Extraordinary" to Our Customers * Innovate with Purpose * Trust and Empower * Build Great Team 3D Systems Littleton: As part of the Healthcare unit of 3D Systems, the Littleton facility acts as a service bureau to enable customers without the expertise, capital, or desire to additively manufacture their products. We are experts in digital workflows, patient-specific devices, and five different kinds of 3D printing. The Quality department serves both the Virtual Surgical Planning as well as the Contract Manufacturing product lines with plastic and metal additive manufacturing. What We Are Looking For: The 3D Systems site in Littleton, Colorado is looking for a skilled Quality Engineer III to augment the Development Quality team under the direction of the Quality Engineering Manager. The mission of the Development Quality team is to ensure 3D Systems' products and/or services for new customers provide a high level of quality that meets expectations. This position will support the Product Development and Solutions team to develop new 3D Systems' and contract manufacturing products through a product development process. We are seeking a dynamic Quality Engineer professional who has proven success developing and implementing quality control systems, monitoring and analyzing quality performance, and ensuring quality specifications are met. If you are an accomplished industry champion who thrives in a highly innovative, emergent technology environment where you have the opportunity to own and execute on Development Quality Engineer deliverables, this is the position for you! What You Will Do: * Develop Product Quality Processes: Utilize existing processes and inspection methods and augment capabilities with new processes to meet technical requirements of internally and externally driven projects. Specify, justify financially, develop, and implement new methods for ensuring the quality of product produced at 3D Systems. * Evaluate product and process risk: Lead risk management activities for assigned products. Identify, develop and implement appropriate mitigating controls to ensure consistent realization of product quality. * Conduct Process and Product Validation: Participate in cross functional team to develop and execute test protocols for the verification and validation of new products, materials, equipment, software, and processes. Perform statistical analysis of data to assess viability of product designs and manufacturing processes. * Perform Measurement System Analysis: Identify and evaluate accuracy, precision and stability of measurement methods to ensure suitability for use in determining product acceptance. * Resolve technical issues: Follow developed processes and projects through design transfer and in to the first year of volume production. Working within a cross-functional team, ensure that insufficiently developed processes are remediated, work instructions are updated, and scrap is minimized. Document the results of investigation and resolution through the CAPA, NCR, or Deviation processes. * Qualify New Suppliers: Evaluate new candidate suppliers to ensure they meet the operational and quality needs of 3D Systems as governed by applicable regulatory bodies such as the FDA. * Facilitate Design Control Process: Following internal procedures for product and process development, participate in the transfer of new projects into Manufacturing. Ensure that all required quality documentation is complete and released. * Navigate Product and Process Requirements: Participate in project meetings and lead efforts to translate and understand part, project, and validation requirements. Participate in complaint investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality. * Create Device Master Records: Author work instructions in visual format for the inspection and release of product. Implement all changes via the formal document control system. * Perform Batch Release: Review device history records, ensure compliance to predetermined specifications, and generate product release documentation, including certificates of analysis and conformity. What You Will Need: * BS degree in engineering or related field, or suitable combination of education, skills and experience. * Certification as a Quality Engineer (CQE) or Reliability Engineer (CRE) granted through the American Society of Quality (ASQ) is preferred. * 5-8 years of experience in a Quality Engineering role, or an equivalent combination of education and experience. * Working knowledge of cGMP and ISO 13485 Quality System. * Applied understanding of Geometric Dimensioning and Tolerancing. * Practical understanding of common measuring equipment and methods. * Ability to read and understand specifications across a number of products and materials. * Ability to analyze and develop engineering processes for use in advanced technology implementations. * Experience in preparing technical documentation. * 6 Sigma Green Belt. What You Want To Know: * Salary Range: $91,900 - $120,000 annually (Salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data) * In addition to a salary, this position is eligible for an annual bonus based upon company performance. * 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 8 holidays per year are also provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match. Come be a part of an organization that offers diversity with some of the world's most dynamic and forward-thinking talent! We're always eager to learn about the skills and talents that applicants may bring to our organization! Click "Apply Online" so that we may open a dialogue and start learning more about you. Thank you for choosing 3D Systems as your choice of career path. We're confident you made the right choice! Title: *Development Quality Engineer III * Location: CO-Littleton Requisition ID: 2300005B

Keywords: 3D Systems, Littleton , Development Quality Engineer III, Engineering , Littleton, Colorado