Sterilization Engineer II
Core
Ensuring sterilization processes (specifically Ethylene Oxide) comply with regulatory and quality standards for medical devices.
Role type
Sterilization Engineer
Builds
Validated sterilization processes and microbiological controls for medical devices
Domain
Medical Device Manufacturing / Sterility Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EO sterilization process validation, regulatory compliance (FDA, ISO 11135, ISO 13485), microbiological testing (bioburden, endotoxin, EO residual), root cause analysis, CAPA implementation, risk assessment (FMEA), equipment calibration, project management
Preferred skills
Advanced degree (Master's), knowledge of parametric release processing, cleanroom control, Minitab proficiency
Technologies
Minitab, QMS systems
Responsibilities
Lead sterilization validations and process improvements, navigate QMS to create/release validation documentation, collaborate with global teams on sterilization strategy, oversee equipment requalification and maintenance, provide technical support for root cause analysis and CAPAs, participate in internal and inter-facility audits
Seniority
Mid-level IC with mentorship responsibilities