Description
About the Role:
The 3D Systems facility in Littleton, Colorado is expanding and seeking a skilled Validation/Process Engineer to join the Application Innovation Group (AIG). The AIG team's mission is to accelerate the development of advanced applications and innovative additive manufacturing solutions for 3D Systems, our customers, and society as a whole. By leveraging expertise in technology, software, materials, and services, we deliver industry-leading solutions that help customers achieve exceptional outcomes.
The Validation/Process Engineer will serve as a key interface between internal and external customers, supporting the implementation of process controls and validation activities for 3D printing platforms and heat treatment processes. This role ensures compliance with quality and regulatory standards, including ISO 13485, AS9100, ISO 9001, FDA Quality System Regulations (QSR), Medical Device Directive (MDD), and various aerospace industry requirements. The position is also responsible for supporting the development, qualification, and execution of manufacturing processes and quality systems in accordance with both internal standards and customer-specific requirements.
In this role, you will collaborate closely with Application Engineering colleagues and Service Technicians across the globe, while leveraging the expertise and experience of professionals from other 3D Systems divisions. You will be responsible for assessing customer requirements, defining project scope, and implementing effective solutions. Utilizing strong project management principles, you will lead projects to successful completion, ensuring they are delivered on time, within budget, and in alignment with customer expectations and regulatory requirements.
What We Are Looking For:
• Lead the application and process development of new technologies to expand and enhance the capabilities of 3D Systems' additive manufacturing solutions.
• Develop and execute verification and validation (V&V) plans, including the creation of test protocols, statistical analysis of results, and preparation of comprehensive test reports.
• Coordinate and execute process qualifications, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for metal additive manufacturing equipment used internally and at customer sites.
• Develop, optimize, and validate 3D printing and heat treatment processes to ensure consistent quality and performance.
• Contribute to the development, implementation, and maintenance of risk management processes in accordance with applicable industry and regulatory standards.
• Establish and maintain process controls to ensure product quality, process consistency, and regulatory compliance.
• Participate in the preparation, compilation, and review of technical documentation supporting domestic and international regulatory submissions.
• Provide guidance and support to project teams to ensure compliance with applicable quality and regulatory requirements, including EN/AS9100, EASA/FAA regulations, FDA Quality System Regulations (QSR), European Medical Device Regulation (MDR), ISO 13485, ISO 9001, and other relevant ISO and EN standards.
• Support the execution, maintenance, and continuous improvement of the Quality Management System (QMS).
• Collaborate with cross-functional project teams and both internal and external stakeholders, providing validation expertise to support the development and implementation of new products, applications, and manufacturing processes utilizing 3D Systems technologies.
Disclaimer: This job description outlines the primary duties, responsibilities, and authority associated with this position. It is not intended to be an exhaustive list of all activities, duties, or responsibilities. Employees may be required to perform other job-related duties as assigned to meet business needs.
Qualifications
What You Will Bring:
• 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 other cGMP-compliant industries.
• Experience with Additive Manufacturing technologies is preferred.
• Working knowledge of cGMP requirements and quality management systems, including EN/AS9100 and ISO 13485, is highly desirable.
• Demonstrated ability to analyze, develop, and optimize engineering processes supporting advanced technology implementations.
• Experience in quality assurance, process validation, and reliability engineering within a manufacturing environment is preferred.
• Strong commitment to delivering exceptional customer service and building positive customer relationships.
• Professional presence with excellent verbal, written, and interpersonal communication skills.
• Proficient computer skills, including experience with standard business and engineering software applications.
• Ability and willingness to travel domestically and internationally up to 20% of the time.
We'll be accepting applications until the position is filled.
