Principal Engineer - Device/Combination Product Sterilization
Core
Technical expert evaluating, validating, and optimizing sterilization processes for medical devices and combination products across the product lifecycle.
Role type
Principal Engineer - Device/Combination Product Sterilization
Builds
Life-saving healthcare solutions (medical devices and combination products)
Domain
Medical Devices / Biotech / Healthcare / Sterilization Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterilization process evaluation and selection, Validation protocol development (IQ/OQ/PQ), Root cause analysis, Risk management (FMEA, ISO 14971), Design control frameworks, Contract sterilizer oversight, Statistical test-method validation
Preferred skills
Electron beam/ethylene oxide/steam sterilization experience, Microbiological testing knowledge, Biocompatibility standards knowledge, Matrix organization experience
Technologies
ISO 11135, ISO 14937, ISO 11137, ISO 13485, ISO 11138, ISO 14161, ISO 10993
Responsibilities
Lead sterilization strategy for new primary containers and devices, Drive validation and requalification of processes and equipment, Enhance quality and compliance through root cause analysis and continuous improvement, Cross-functional collaboration with marketing, clinical, and regulatory teams, External partner oversight of contract sterilizers, Execute test-method validation projects
Seniority
Principal, hands-on IC with strategy & mentorship
