NPS Validation Engineer

Hi,
Hope you are doing well. We have the position below.

Position: NPS Validation Engineer – NMD
Location: Plano TX
Long Term

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.
 
Key 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

Required Qualifications:
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

Preferred Qualifications
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