Senior Microbiologist
Core
Subject-matter expert for microbiological safety across the product lifecycle, developing strategies, leading testing, and ensuring compliance for medical devices.
Role type
Senior Microbiologist (Medical Device)
Builds
Medical devices (dialysis systems) and associated fluid pathways
Domain
Medical Device / Dialysis / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological risk assessment, bioburden testing, bacterial endotoxin testing, microbial identification, water system microbiology, cleaning and disinfection validation, regulatory compliance (FDA/ISO), technical protocol authoring, data interpretation, cross-functional collaboration
Preferred skills
Dialysis system experience, reusable medical equipment, water treatment, automated cleaning cycles, FDA submission support, contract laboratory management, mentoring
Technologies
None explicitly listed beyond general lab equipment
Responsibilities
Develop and execute microbiological strategies for product development and manufacturing; Lead microbiological risk assessments for products and processes; Establish acceptance criteria and test methods for bioburden and endotoxins; Support validation of cleaning and disinfection processes; Author and review protocols, reports, and regulatory documentation; Evaluate test results and lead investigations; Qualify and oversee external microbiology laboratories; Partner with Regulatory Affairs on microbiology-related questions; Mentor colleagues and support audits
Seniority
Senior, hands-on IC with significant influence
