Intermediate Product Development Quality Engineer

3D Systems•Littleton, CO

1d•Hybrid

About The Position

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.

Requirements

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 management system standards such as ISO 13485 (Medical Devices Quality Management Systems), AS9100 (Aerospace Quality Management Systems), ISO 14971 (Application of Risk Management to Medical Devices), and FDA 21 CFR Part 820.
Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis.
Experience with product and process validation, design control, and risk management.
Excellent problem-solving and analytical skills.
Strong communication and interpersonal skills to collaborate effectively with cross-functional teams and external customers.
Strong project management skills.
Detail-oriented with a high level of accuracy in documentation.
Ability to work independently and prioritize tasks in a fast-paced environment.

Nice To Haves

Applied experience with and understanding of additive manufacturing a plus.
Experience in a regulated industry (medical device, aerospace, or industrial/semiconductor)
Quality certifications (e.g., ASQ Certified Quality Engineer)

Responsibilities

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.