US_East | Product​/System & PLM Engineer_L

Location:

Plano, TX. Background and Meet and Greet: MANDATORY.

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.

• 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

• Bachelor's degree in Engineering, Computer Science, or related technical field
• Minimum 5 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

• 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 life cycles