Senior Validation Engineer

Summary of Position

The Quality Validation Engineer develops and executes validation protocols, supports risk-based validation strategies, prepares technical documentation, and assists with maintaining compliance with applicable quality systems and regulatory requirements.

The position will also support activities related to device cleanliness, sterility assurance, biocompatibility, bioburden, sterilization, and analytical testing while contributing to continuous improvement and quality initiatives.

• Bachelor's degree in Engineering, Science, Quality, or a related technical discipline with 5+ years of experience within the medical device industry, with exposure to validation, verification, quality engineering, or manufacturing engineering activities.
• Working knowledge of IQ, OQ, PQ, and other process and equipment qualification methodologies.
• Ability to develop and execute validation and verification protocols, test methods, and technical reports.
• Understanding of risk-based validation principles, including pFMEA, FMEA, and other risk assessment methodologies.
• Working knowledge of medical device quality systems and applicable FDA and ISO requirements.
• Ability to support validation activities for manufacturing processes, equipment, materials, inspection methods, and new product introductions.
• Familiarity with process capability studies, inspection requirements, measurement systems, and validation data analysis.
• Ability to investigate manufacturing deviations, nonconformances, process anomalies, and validation-related issues.

• Experience supporting validation and verification activities for implantable medical devices, including product materials, manufacturing processes, cleaning, packaging, and sterilization.
• Knowledge of biocompatibility requirements and testing applicable to implantable medical devices and medical device materials.
• Understanding of bioburden testing and reduction, sterility assurance, and microbial control strategies.
• Exposure to gamma irradiation sterilization, including sterilization dose considerations, dose audits, dose mapping, and evaluation of potential impacts on product materials and performance.
• Familiarity with endotoxin testing, environmental monitoring, microbiological testing, or other sterility assurance activities.
• Experience supporting analytical testing laboratories, including equipment qualification, calibration, maintenance, and test method activities.
• ASQ certification or other quality-related certification is a plus.