Process/Validation Engineer

3D Systems • Littleton, CO

9d • Onsite

About The Position

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.

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 other cGMP-compliant industries.
• Demonstrated ability to analyze, develop, and optimize engineering processes supporting advanced technology implementations.
• 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.

Nice To Haves

• 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.
• Experience in quality assurance, process validation, and reliability engineering within a manufacturing environment is preferred.

Responsibilities

• 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.

Benefits

• Competitive Pay: ($76,400- $107,000 annually)
• Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays, flexible working schedules through our paid time off (PTO) policy.
• 401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution.
• Comprehensive Health & Wellness Plans: We want to be here for our employees throughout all stages of life, which is why we offer a wide range of resources, information, and support during your career with us.
• Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 13 countries worldwide.
• Innovative Culture: Innovation is at the heart of what we do! Since our founding in 1986 by Chuck Hull, the inventor of 3D printing, we have continuously pushed the boundaries of what is possible with additive manufacturing. When you join 3D, you will have the opportunity to work with cutting edge technology in an innovative and collaborative culture!
• Talent Development: At 3D Systems, we invest in talent programs to support employees with opportunities to grow, contribute, develop, and thrive in their careers.
• Connection & Engagement Opportunities: We strive to cultivate an environment where our diverse global workforce can connect and thrive. Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program, are just a few examples of how you will be empowered to build connections, celebrate wins, and make a meaningful impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level