Development Quality Engineer I

What We Are Looking For:

The 3D Systems site in Littleton, Colorado needs a skilled Quality Engineer to augment the Development Quality team under the direction of the Quality Engineering Supervisor. The mission of the Development Quality team is to ensure 3D Systems’ products and/or services for new customers provide a high level of quality that meets expectations. This position will support the Product Development and Solutions team to develop new 3D Systems’ and contract manufacturing products through a product development process.

Organization:

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.

Performance Objectives:

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

1. Develop Product Quality Processes: Utilize existing processes and inspection methods and augment capabilities with new processes to meet technical requirements of internally and externally driven projects. Specify, justify financially, develop, and implement new methods for ensuring the quality of product produced at 3D Systems.

2. Conduct Process and Product Validation: Participate in cross functional team to develop and execute test protocols for the verification and validation of new products, materials, equipment, software, and processes. Perform statistical analysis of data to assess viability of product designs and manufacturing processes.

3. Perform Measurement System Analysis: Identify and evaluate measurement systems to ensure accuracy, precision and stability used to assess product conformity.

4. Resolve technical issues: Follow developed processes and projects through design transfer and in to the first year of volume production. Working within a cross-functional team, ensure that insufficiently developed processes are remediated, work instructions are updated, and scrap is minimized. Document the results of investigation and resolution through the CAPA, NCRs or Deviation processes.

5. Qualify New Suppliers: Evaluate new candidate suppliers to ensure they meet the operational and quality needs of 3D Systems as governed by applicable regulatory bodies such as the FDA.

6. Facilitate Design Control Process: Following internal procedures for product and process development, participate in the transfer of new projects into Manufacturing. Ensure that all required quality documentation is complete and released.

7. Navigate Product and Process Requirements: Participate in project meetings and lead efforts to translate and understand part, project, and validation requirements. Participate in complaint investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality.

8. Create Device Master Records: Author work instructions in visual format for the inspection and release of product. Implement all changes via the formal document control system.

9. Perform Batch Release: Review device history records, ensure compliance to predetermined specifications, and generate product release documentation, including certificates of analysis and conformity.

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.

Qualifications

Education, Training, and Experience

• BS degree in engineering or related field or an equivalent combination of education and experience.

• 1 year of experience in a Quality Engineering role

  
  

Knowledge, Skills & Abilities

• 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.

The Good Stuff!

• Salary Range: $68,000 - $82,000 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 eligible 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 8 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.

3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin or because he or she is an individual with a disability or a disable veteran, Armed Forces service medal veteran (referred to collectively as "protected veterans"). The Company also provides applicants with equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including, but not limited to, lactation.

Primary Location: US-CO-Littleton

Work Locations: USA-CO-Littleton

Job Level: Entry Level

Travel: Yes, 10 % of the Time

Type of Position: Employee

Job Posting: Jun 19, 2023, 10:11:02 AM