Senior Validation Engineer

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Overview

We are supporting a prominent medical device manufacturer in expanding their engineering team for high-visibility mammography product lines. This position plays a key role in enhancing manufacturing validation processes, reinforcing quality systems, and ensuring compliance through strong risk management and validation practices.

Key Responsibilities

• Review and strengthen existing PFMEAs by identifying failure modes, risk gaps, and improving mitigation controls.
• Lead and execute Process Validation activities (IQ/OQ/PQ), including protocol authoring, execution, and final reporting.
• Develop risk-based validation strategies and clearly define acceptance criteria with proper traceability to risk assessments.
• Perform and document Test Method Validation (TMV) to ensure accuracy, reliability, and compliance
• Drive deviation investigations, conduct root cause analysis, and implement effective corrective actions (CAPA).
• Ensure proper linkage between risk assessments, validation activities, deviations, and change control within the QMS.
• Collaborate with Manufacturing, Quality, and cross-functional teams to maintain regulatory compliance and support continuous improvement initiatives.
  
  

Qualifications

• Bachelor s degree in Engineering (Mechanical, Biomedical, Industrial, or related)
• 4-5 years of medical device experience
• Experience with established med device companies (e.g., Stryker, Johnson & Johnson)
• Strong experience in Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV)
• PFMEA and remediation experience preferred
• Knowledge of FDA regulations and ISO 13485