Non Product Validation Engineer

Capgemini • Dallas, TX

2d • Onsite

About The Position

We are seeking a detail-oriented Non-Product Software (NPS) Validation Engineer to join our medical technology team. This role is responsible for ensuring that all non-product software systems used in our quality management system processes comply with ISO 13485 standards and applicable regulatory requirements. The ideal candidate will have strong technical skills combined with a thorough understanding of medical device quality systems, validation methodologies, and embedded systems experience.
Location
This role will be on-site in Dallas, TX

Requirements

• Bachelor's degree in Engineering, Computer Science, or related technical field
• 1-3 years of experience in software validation within a regulated medical device environment
• Demonstrated knowledge of ISO 13485 requirements for non-product software validation
• Proficiency in risk management techniques (FMEA, FTA) as applied to software systems
• Strong understanding of 21 CFR Part 11 compliance for electronic records/signatures
• Excellent documentation and technical writing skills
• Strong analytical and problem-solving abilities
• Effective communication skills with the ability to explain technical concepts to non-technical stakeholders

Nice To Haves

• Master's degree in related field
• Knowledge of additional regulatory frameworks (FDA QSR, EU MDR, MDSAP)
• Background in computer system validation methodologies
• Experience with validation of computerized systems in medical device environments
• Familiarity with embedded software development lifecycles

Responsibilities

• Plan, execute, and document validation activities for non-product software systems in accordance with ISO 13485 requirements
• Develop validation protocols including requirements specifications, risk assessments, test plans, and validation reports
• Conduct gap analyses of existing systems against regulatory requirements
• Create and maintain validation documentation including traceability matrices
• Collaborate with IT, Quality, and other cross-functional teams to ensure software systems meet business needs while maintaining compliance
• Participate in internal and external audits related to software validation
• Support change control processes for validated systems
• Develop and implement validation strategies for new software implementations
• Monitor and evaluate system performance to ensure continued validated state

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level