Senior Microbiologist-Sterilization Engineer
Core
Lead microbiology and sterility assurance activities for terminally sterilized medical devices, including validation, monitoring, and risk management across the manufacturing lifecycle.
Role type
Senior Microbiologist-Sterilization Engineer
Builds
Sterile medical devices and validated sterilization processes
Domain
Medical device manufacturing / Sterilization engineering
Required skills
Microbiology, Sterilization validation (EtO/Radiation), Cleanroom qualification, Contamination control, Root cause analysis, Risk assessment, Regulatory compliance (FDA/ISO), Data analysis (via careerplan.io/jobs/R78104-2-senior-microbiologist-sterilization-engineer-at-medtronic)
Preferred skills
Industrial EtO/Radiation sterilization experience, cGMP knowledge, Statistical analysis tools (Minitab/Power BI), AAMI/ASQ certifications
Technologies
Ethylene oxide sterilizers, Radiation sterilizers, Cleanroom monitoring systems, Electronic quality management systems
Responsibilities
Execute sterilization validations and routine monitoring; Analyze microbiology and sterilization data to identify trends; Lead investigations and CAPAs for quality events; Assess changes to processes and facilities for sterility impact; Develop and maintain technical protocols and risk assessments; Partner with cross-functional teams to support production and audits.
Seniority
Senior, hands-on IC