Senior Software Quality & Validation Engineer

3D Systems; Littleton (CO); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Competitive Pay

Paid Leave

401(k) Matching

Health & Wellness Plans

Global Team

Innovative Culture

Talent Development

Engagement Opportunities

Job summary

3D Systems in Littleton, CO is seeking a Senior Software Validation Quality Engineer to oversee software validation and CSA within a regulated medical device environment. The role requires onsite presence five days a week and travel.

You will guide risk-based validation, develop validation plans, and support audits, CAPA, and continuous improvement across Quality and IT teams. Preference for CSQE/ISTQB certifications and experience with eQMS/ERP/MES.

Qualifications

• 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).
• Familiarity with FDA quality system regulations, electronic records requirements, and ISO 13485 or equivalent standards.
• Experience conducting software risk assessments, validation reviews, and change impact assessments.

Responsibilities

• Maintain and continuously improve the software validation and CSA program.
• Provide guidance on software risk assessments and validation strategies.
• Develop and maintain validation plans, protocols, reports, and related documentation.
• Support validated QMS, ERP, manufacturing, laboratory, and business systems.
• Collaborate with cross-functional teams across global sites.

Skills

Quality systems

Regulatory compliance

Software validation

CSV/CSA knowledge

Technical writing

Education

Bachelors degree

Tools

eQMS

ERP

MES

Job description

Senior Software Quality & Validation Engineer - 26000085

Description

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.

Qualifications

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

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 80127

Travel

Yes, 25 % of the Time

About 3D Systems

3D Systems provides the most advanced and comprehensive 3D digital design and fabrication solutions available today, including 3D printers, print materials and cloud-sourced custom parts. Its powerful ecosystem transforms entire industries by empowering professionals and consumers everywhere to bring their ideas to life using its vast material selection, including plastics, metals, ceramics and edibles. Our leading personalized medicine capabilities save lives and include end‑to‑end simulation, training and planning, and printing of surgical instruments and devices for personalized surgery and patient specific medical and dental devices. Its democratized 3D digital design, fabrication and inspection products provide seamless interoperabilityand incorporate the latest immersive computing technologies. Our products and services disrupt traditional methods, deliver improved results and empower its customers to .manufacture the future now