Process/Validation Engineer

3D Systems•Littleton, CO

9d•$76,400 - $107,000•Onsite

About The Position

3D Systems is seeking a Validation/Process Engineer for its expanding facility in Littleton, Colorado, to join the Application Innovation Group (AIG). The AIG accelerates the development of advanced applications and additive manufacturing solutions by combining expertise in technology, software, materials, and services. The engineer serves as an interface between internal and external customers, supporting process controls and validation for 3D printing platforms and heat treatment processes. The role supports development, qualification, and execution of manufacturing processes and quality systems in accordance with internal standards, customer requirements, and applicable quality and regulatory requirements. Standards and regulations referenced include ISO 13485, AS9100, ISO 9001, FDA Quality System Regulations, medical-device regulations, and aerospace requirements. Working with Application Engineering colleagues, Service Technicians, and professionals across 3D Systems, the engineer assesses customer requirements, defines project scope, and implements solutions. The role uses project management principles to deliver projects on time, within budget, and in alignment with customer expectations and regulatory requirements. The position also contributes to application and process development, verification and validation, process qualification, technical documentation, risk management, and continuous improvement of the Quality Management System.

Requirements

Bachelor's degree in Engineering, Science, or a related technical field, or an equivalent combination of education and relevant experience.
Minimum of 3 to 5 years of experience in a regulated manufacturing environment, such as medical device, pharmaceutical, aerospace, or another cGMP-compliant industry.
Demonstrated ability to analyze, develop, and optimize engineering processes supporting advanced technology implementations.
Strong commitment to customer service and building positive customer relationships.
Excellent verbal, written, and interpersonal communication skills, with a professional presence.
Proficient computer skills, including standard business and engineering software applications.
Ability and willingness to travel domestically and internationally up to 20% of the time.

Nice To Haves

Experience with Additive Manufacturing technologies.
Working knowledge of cGMP requirements and quality management systems, including EN/AS9100 and ISO 13485.
Experience in quality assurance, process validation, and reliability engineering within a manufacturing environment.

Responsibilities

Lead application and process development for new technologies that expand and enhance 3D Systems additive manufacturing solutions.
Develop and execute verification and validation plans, including test protocols, statistical analysis, and comprehensive test reports.
Coordinate and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for metal additive manufacturing equipment, both internally and at customer sites.
Develop, optimize, and validate 3D printing and heat treatment processes.
Contribute to the development, implementation, and maintenance of risk management processes in accordance with applicable standards.
Establish and maintain process controls to support product quality, process consistency, and regulatory compliance.
Participate in preparing, compiling, and reviewing technical documentation for domestic and international regulatory submissions.
Guide and support project teams on applicable quality and regulatory requirements, including EN/AS9100, EASA/FAA regulations, FDA QSR, European MDR, ISO 13485, ISO 9001, and other relevant ISO and EN standards.
Support execution, maintenance, and continual improvement of the Quality Management System (QMS).
Collaborate with cross-functional project teams and internal and external stakeholders, providing validation expertise for new products, applications, and manufacturing processes using 3D Systems technologies.
Assess customer requirements, define project scope, and implement solutions while managing projects to meet timing, budget, customer, and regulatory expectations.
Travel domestically and internationally, as required, up to 20% of the time.