Validation Engineer, Sterility Assurance
Core
Support sterilization processes for single-use surgical instruments and accessories, ensuring safety and efficacy through bioburden testing and compliance.
Role type
Validation Engineer (Sterility Assurance)
Builds
Single-use daVinci® surgical instruments and accessories
Domain
Medical device manufacturing / Sterilization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology lab experience, Ethylene oxide sterilization knowledge, radiation sterilization knowledge, ISO 11135/11137 standards, bioburden program management, data analysis, incident investigation, corrective/preventative action development, project risk management, hands-on engineering skills
Preferred skills
Masters degree, international travel experience
Technologies
MS Office Suite
Responsibilities
Manage routine Ethylene Oxide (EO) and radiation bioburden testing, support internal microbiology lab with validated methods, interpret bioburden results and investigate excursions, oversee multiple projects involving cross-functional collaboration, provide technical support for sterilization release activities, maintain bioburden procedures per recognized standards, conduct and approve incident investigations, assist with compliance audits for external facilities
Seniority
Mid-level, hands-on IC