Microbiologist

About the role

Enovis is seeking a Microbiologist to join its Quality Assurance team in Austin, TX. You will support the development and release of medical devices by ensuring sterility, cleanliness, and regulatory compliance through rigorous microbiological testing and validation.

Key responsibilities

• Perform sterilization validations using gamma, VHP, and H2O2 gas plasma methods.
• Process reusable devices, including cleaning, disinfection, and sterilization.
• Generate protocols, coordinate with test laboratories, and author technical reports.
• Manage dose‑audit programs and annual sterilizer re‑qualification.
• Support product development for new implants, defining testing strategies for sterility and cleanliness.
• Monitor water systems, ISO Class 7 cleanroom environments, and product bioburden.
• Interpret microbiological cultures, environmental monitoring data, sterility tests, chemical characterization, cytotoxicity testing, and microbial assays.
• Assist with process or design changes, supplier evaluations, and regulatory submissions to ensure FDA and ISO compliance.
• Perform additional duties as required.

Required profile

• Bachelor’s degree in microbiology or biology with at least 1 year of relevant experience.
• Background in medical devices or another highly regulated industry; knowledge of ISO 13485 preferred.
• Experience in technical writing and report preparation.
• Proficiency with Microsoft Office Suite.
• No travel required.

Required skills

• Sterilization validation (gamma, VHP, H2O2 gas plasma)
• Reusable device processing (cleaning, disinfection, sterilization)
• Protocol development and technical report writing
• Dose‑audit program management
• Cleanroom environmental monitoring (ISO Class 7)
• Water system monitoring
• Microbiological culture analysis
• Environmental monitoring
• Sterility testing
• Chemical characterization
• Cytotoxicity testing
• Microbial assays
• FDA compliance
• ISO 13485 knowledge
• Microsoft Office Suite