3D Systems Corporation

Senior Software Quality & Validation Engineer

3D Systems Corporation • $75K — $95K *
Littleton, CO 80123In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Quality, Regulatory, Computer Science, Information Systems, or related field
  • 4+ years of experience in software quality engineering or validation in a regulated industry
  • Strong knowledge of software validation principles in regulated environments
  • Familiarity with FDA 21 CFR Part 820 and Part 11, ISO 13485, AS9100, and ISO TIR80002-2:2017
  • Experience leading or improving software validation processes
  • Ability to lead validation efforts and influence cross-functional teams
  • Strong technical writing and problem-solving skills

Responsibilities

  • Own and maintain the software validation process for Production Quality System Software (PQSS)
  • Evaluate and improve the software validation framework for compliance with regulatory standards
  • Establish risk-based validation methodologies that are efficient and scalable
  • Define comprehensive validation strategies including planning and reporting requirements
  • Collaborate with software and system owners on validation deliverables
  • Provide guidance and expertise throughout validation activities
  • Review and approve validation documentation for compliance

Benefits

  • Structured enhancement opportunities in software validation processes
  • Collaboration with cross-functional teams across global sites
  • Hands-on role in ensuring compliance with critical industry standards
  • Access to a supportive environment for learning and professional growth
  • Involvement in risk management and system lifecycle controls
Full Job Description
Description

What We Are Looking For

The Software Quality Engineer leads global ownership and continuous improvement of the software validation process for Production Quality System Software (PQSS) within Quality and manufacturing environments. This role ensures validation activities comply with FDA, ISO 13485, AS9100, and ISO TIR[redacted] requirements. As the global SME and process owner, this individual establishes and enhances risk-based validation procedures and lifecycle controls, partnering cross-functionally with Quality, IT, Manufacturing, and system owners across multiple sites to maintain compliance and validated system integrity.

Onsite

This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.

What You Will Do

  • Own and maintain the software validation process for Production Quality System Software (PQSS), including procedures, templates, and validation standards
  • Evaluate and improve the software validation framework to ensure alignment with ISO TIR80002:2017, FDA regulations, ISO 13485, AS9100 and industry best practices
  • Establish risk-based validation methodologies that are scalable, efficient and compliant
  • Define validation strategies, including validation planning, risk assessment approach, user requirement expectations, protocol structure, and reporting requirements
  • Collaborate with software and system owners to ensure validation deliverables are appropriately developed in accordance with validation requirements
  • Provide guidance, support, and subject matter expertise throughout validation activities to ensure compliant execution
  • Review and approve validation deliverables to ensure completeness, traceability, and compliance with established procedures
  • Ensure validation requirements are properly applied to new systems, system changes, and upgrades
  • Ensure software remains in a validated state through effective integration with change control
  • Serve as primary quality SME for software validation for Littleton and Leuven sites
  • Note: This role focuses on software validation, quality systems, and regulatory compliance. It does not involve software development or coding.


Qualifications

What You Will Bring

Education and Experience

  • Bachelor's degree in Engineering, Quality, Regulatory, Computer Science, Information Systems, or related 4+ years of work experience in software quality engineering
  • Minimum 4 years of experience in software quality, software validation, or computer system validation in a regulated industry


Required Skills/Abilities

  • Strong knowledge of software validation principles for Production & Quality System Software in regulated industries
  • Working knowledge of FDA 21 CFR Part 820 and Part 11, ISO 13485, AS9100, and/or ISO TIR80002-2:2017
  • Experience in owning, improving, or leading software validation processes
  • Understanding risk-based validation methodologies and software lifecycle management
  • Strong technical writing, problem solving and organizational skills
  • Ability to lead validation efforts and influence cross-functional stakeholders
  • Ability to identify process gaps and implement structured improvements


Preferred Skills & Experience

  • Experience validating eQMS, ERP, MES, or manufacturing support software
  • Experience in medical device, FDA, aerospace or other regulated industry
  • CSQE or ISTQB certification preferred


Applications accepted online through October 20th, 2026

#LI-MP1

About 3D Systems Corporation

3D Systems Corporation is a leading provider of 3D printing solutions, including 3D printers, print materials, software, on-demand manufacturing services, and digital design tools. The company serves a wide range of industries, including aerospace, automotive, healthcare, dental, and consumer goods. 3D Systems was founded in 1986 and has since grown to become a global leader in the 3D printing industry, with operations in the Americas, Europe, and Asia. The company is committed to advancing the adoption of 3D printing technology and enabling its customers to create innovative products and solutions.
Learn more about 3D Systems Corporation
Size
1,721 employees
Market Cap
$941.6 million
Industry
Consumer Technology
Net Income
-$149.5 million
Founded
1986
5 Year Trend
-0.6%
Revenue
$557.2 million
NASDAQ
DDD
* Ladders Estimates

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