What We Are Looking For

The 3D Systems site in Littleton, Colorado is expanding rapidly and needs a skilled Quality Engineer to augment the Direct Metals Printing (DMP) Team under the direction of the Production Quality Manager. The mission of the DMP Quality Engineer is to ensure 3D System's products or services provide a high level of quality that meets customer expectations. Our pace of growth is only matched by the pace at which our customers expect their new and innovative products to be delivered.

Who We Are

As part of the Healthcare unit of 3D Systems, the Littleton facility acts as a service bureau to enable customers without the expertise, capital, or desire to additively manufacture their products. We are experts in digital workflows, patient-specific devices, and five different kinds of 3D printing. The Quality department serves both the Virtual Surgical Planning as well as the Contract Manufacturing product lines with plastic and metal additive manufacturing.

What You Will Do

The following performance objectives will determine job success for this position:

Develop Product Quality Processes: Utilize existing processes and inspection methods and augment capabilities with new processes to meet technical requirements. Specify, justify financially, develop, and implement new methods for ensuring the quality of product produced at 3D Systems. Perform Product Release: Review device history records, ensure compliance to predetermined specifications, and generate product release documentation, including certificates of analysis and conformity. Create Device Master Records: Author work instructions and supporting documentation for the inspection and release of product. Implement all changes via the formal document control system. Navigate Customer Requirements: Lead efforts to translate and understand product requirements. Participate in complaint and returned product investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality. Resolve technical issues: Lead efforts to ensure that manufacturing and quality issues are remediated, work instructions are updated, and scrap is minimized. Document the results of investigation and resolution through the CAPA, NMR, or Deviation processes. Perform Measurement System Analysis: Identify and evaluate measurement systems to ensure accuracy, precision and stability used to assess product conformity. NCR/CAPA/Complaints: Ensure all NCR/CAPA/Complaints are performed with appropriate tools and in a timely manner.

This document represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described.What We Are Looking For

Education and Training

BS degree in engineering or related field

Experience

5-10 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or food manufacture.

Knowledge, Skills & Abilities

Quality assurance and reliability experience supporting product manufacturing is preferred. Working knowledge of cGMP and ISO 13485 Quality System Ability to read and understand specifications across a number of products and materials. Ability to analyze and develop engineering processes for use in advanced technology implementations. Experience in preparing technical documentation. CAPA/NCR/Complaint closure experience Experience with standardized ROOT CAUSE identification tools Proficient with MSA's and Statistical Analysis

The 3D Systems Advantage!

Salary Range: $85,000 - $105,000 annually (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data) In addition to a salary, this position is e igible for an annual bonus based upon company performance. 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 9 holidays per year are also provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.

Applications accepted online through October 2, 2024

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity