What We Are Looking For
As an Intermediate Product Development Quality Engineer, you will play a pivotal role in the design, development, and quality assurance processes of cutting-edge additively manufactured products. You will work closely with cross-functional teams on both new product development programs and contract manufacturing engagements, owning customer-facing quality interactions and ensuring compliance with industry regulations. The role reports to the Development Quality Engineering Manager and is based in Littleton, CO
Hybrid Schedule
This role has a hybrid work schedule requiring the person to be onsite 3 days a week.
What’s In It for You!
- Competitive Compensation Package: $75,000 - $95,000 per year. Our employees are the best part of our company. We want you to feel valued, appreciated, and included. Because of this, we make sure your hard work is recognized.
- Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays and a flexible working schedule through our paid time off (PTO) policy. Yep, you read that correctly. We are a Company that values you and makes sure you take time for yourself.
- 401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution.
- Comprehensive Health & Wellness Plans: We offer a comprehensive benefit package that includes medical, dental and vision coverage, company-paid short-term and long-term disability insurance, as well as company-paid basic life insurance that supports you during your career with us. We believe that taking care of our employees is essential, and these benefits reflect our commitment to your health, security, and peace of mind.
- Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team operates across more than 13 countries worldwide. Experience a workplace comprised of talented individuals who are passionate about serving our customers and each other.
- 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 You Will Do
- Collaborate closely with cross-functional product development and contract manufacturing teams to establish, implement, and maintain quality standards throughout the product life cycle.
- Serve as the primary quality point of contact for customer-facing interactions, including customer quality agreements, change control, and audits.
- Develop, execute, and oversee risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, in compliance with applicable industry regulations and standards.
- Provide input and review and approve product and process validation activities.
- Lead and participate in design and process risk analysis and file creation.
- Identify and develop test methods, inspection plans, and quality control procedures.
- Ensure compliance with applicable regulatory requirements and quality standards, such as FDA 21 CFR Part 820, ISO 13485 (medical devices), AS9100 (aerospace), ISO 14971 (risk management), ITAR, and other relevant standards for regulated and high-reliability manufacturing.
- Investigate and address product non-conformances, perform root cause analysis, and implement corrective and preventive actions (CAPA) where appropriate.
- Provide guidance and support to design and engineering teams to address quality concerns and improve product design and manufacturability.
- Assist in supplier quality management and supplier audits to ensure the quality of incoming materials and components.
- Maintain accurate quality documentation, including design history files, risk management files, and test records.
- Collaborate with regulatory affairs and provide input for regulatory submissions where applicable.
- Continuously monitor industry trends and regulatory updates to stay current with best practices and compliance.
What You Will Bring
- Bachelor's degree in engineering, preferably in biomedical, mechanical, aerospace, or a related field; or equivalent skills and work experience.
- 2–4 years of experience in quality engineering or a closely related role that encompasses quality engineering responsibilities.
- Knowledge of quality ma