Senior Software Quality & Validation Engineer
Littleton, CO, United StatesYesterday
Free account needed to apply or save. It takes a minute, and we'll bring you right back to this job.
Skills
21 cfr part 11capaerpiso 13485mesquality management systemsregulatory auditsrisk assessmenttechnical writing
About the role
What We Are Looking For
The Senior Software Validation Quality Engineer is responsible for supporting and maintaining the organization's software validation and Computerized Systems Assurance (CSA) program within a regulated medical device environment. This role provides guidance on software compliance, validation strategy, risk-based decision making, and lifecycle management of computerized systems used throughout the product lifecycle and Quality Management System. The position partners with Quality, Regulatory, Engineering, Operations, Manufacturing, and Information Technology teams across multiple sites to ensure continued compliance with applicable regulatory and quality requirements.
Onsite
This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.
What’s In It For You!
- Competitive Pay: $85,000 - $100,000 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 want to be here for our employees throughout all stages of life, which is why we offer a wide range of resources, information, and support during your career with us.
- Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence 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
- Maintain and continuously improve the software validation and Computerized Systems Assurance (CSA) program.
- Provide guidance on software risk assessments, validation impact assessments, and risk-based validation strategies in accordance with CSV and CSA principles.
- Develop, review, and maintain validation plans, protocols, reports, and related documentation.
- Provide guidance on CSV and CSA approaches for computerized systems.
- Provide guidance to cross-functional teams regarding software validation requirements, risk assessments, and compliance expectations.
- Support validated QMS, ERP, manufacturing, laboratory, and business systems.
- Assess software changes, upgrades, and implementations for validation impact and revalidation requirements.
- Support internal, customer, certification, and regulatory audits related to software validation activities.
- Participate in CAPA, change management, and continuous improvement initiatives.
- Provide cross-functional support to Quality Systems activities as needed.
- Collaborate effectively across global sites and functions.
- Travel Requirement: Approximately 25% domestic and international travel required.
- Note: This role focuses on software validation, quality systems, and regulatory compliance. It does not involve software development or coding.
What We Are Looking For
The Senior Software Validation Quality Engineer is responsible for supporting and maintaining the organization's software validation and Computerized Systems Assurance (CSA) program within a regulated medical device environment. This role provides guidance on software compliance, validation strategy, risk-based decision making, and lifecycle management of computerized systems used throughout the product lifecycle and Quality Management System. The position partners with Quality, Regulatory, Engineering, Operations, Manufacturing, and Information Technology teams across multiple sites to ensure continued compliance with applicable regulatory and quality requirements.
Onsite
This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.
What’s In It For You!
- Competitive Pay: $85,000 - $100,000 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 want to be here for our employees throughout all stages of life, which is why we offer a wide range of resources, information, and support during your career with us.
- Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence 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
- Maintain and continuously improve the software validation and Computerized Systems Assurance (CSA) program.
- Provide guidance on software risk assessments, validation impact assessments, and risk-based validation strategies in accordance with CSV and CSA principles.
- Develop, review, and maintain validation plans, protocols, reports, and related documentation.
- Provide guidance on CSV and CSA approaches for computerized systems.
- Provide guidance to cross-functional teams regarding software validation requirements, risk assessments, and compliance expectations.
- Support validated QMS, ERP, manufacturing, laboratory, and business systems.
- Assess software changes, upgrades, and implementations for validation impact and revalidation requirements.
- Support internal, customer, certification, and regulatory audits related to software validation activities.
- Participate in CAPA, change management, and continuous improvement initiatives.
- Provide cross-functional support to Quality Systems activities as needed.
- Collaborate effectively across global sites and functions.
- Travel Requirement: Approximately 25% domestic and international travel required.
- Note: This role focuses on software validation, quality systems, and regulatory compliance. It does not involve software development or coding.
What You Will Bring
Education and Experience
- Bachelor's degree in a technical, scientific, quality, or related discipline, or equivalent combination of education and experience.
- 4+ years of experience in a regulated industry (medical device, pharmaceutical, biotechnology, aerospace, defense, or similar), including experience supporting CSV, CSA, software validation, or related quality and compliance activities.
Required Skills/Abilities
- Familiarity with FDA quality system regulations, electronic records requirements, and/or quality management system standards such as FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 13485, or equivalent regulated-industry standards.
- Understanding of medical device product lifecycle processes and quality system requirements.
- Experience conducting software risk assessments, validation reviews, and change impact assessments.
- Experience authoring or reviewing validation plans, protocols, reports, and software risk assessments.
- Strong communication, collaboration, and technical writing skills.
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 November 16th, 2026
#LI-MP1
What You Will Bring
Education and Experience
- Bachelor's degree in a technical, scientif