Senior Sterilization Engineer
Core
Lead sterilization validation, requalification, and product adoption programs for next-generation continuous glucose monitoring devices, ensuring regulatory compliance and quality.
Role type
Senior Sterilization Engineer
Builds
Terminally sterilized medical devices (CGM sensors)
Domain
Medical device manufacturing / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Ethylene oxide cycle development, sterilization validation, IQ/OQ/PQ protocol design, ISO 11135/11137 compliance, sterility assurance systems, risk-based evaluations, laboratory testing (bioburden, LAL, environmental monitoring), cross-functional strategy
Preferred skills
Mentorship of sterilization processes, audit support, product disposition characterization
Technologies
Ethylene oxide, ISO 11135, ISO 11137, ISO 10993-7, ISO 11737, ISO 14644, ISO 13485
Responsibilities
Lead sterilization validation and requalification programs; Develop IQ/OQ/PQ protocols and reports; Act as subject matter expert for terminally sterilized devices; Consult on global sterilization strategy; Mentor teams on sterilization best practices
Seniority
Senior, hands-on IC