Technical Fellow – Medical Device Microbiology
About The Position
The Technical Fellow – Medical Device Microbiology is the senior technical leader for microbiology. This role sets technical direction, standards, and decisions to ensure consistent, high-quality, and compliant services. They drive standardization, build technical expertise, and support business growth. This position is intended to lead technical direction across the organization, influence standards and capabilities enterprise-wide, and guide senior technical staff (not responsible for daily lab operations). Some major focus areas of the Technical Fellow are as follows: 1. Standardization & Quality Ensure consistent testing methods, data interpretation, and reporting Reduce variability across teams Support troubleshooting and continuous improvement 2. Regulatory & Strategy Translate FDA, ISO, and USP requirements into clear actions Anticipate industry changes and adapt technical strategies Support growth areas like sterilization, cleaning, and disinfection 3. Talent & Expertise Build and develop SME capabilities Define skill expectations and training priorities Reduce reliance on single experts 4. Governance Serve as the escalation point for complex technical issues Provide clear, binding technical decisions
Requirements
- Advanced degree in Microbiology, Biology, or related field (preferred)
- 12–15+ years of experience in medical device microbiology
- Deep expertise in: Sterility, bioburden, and endotoxin testing
- Deep expertise in: Sterilization processes (Steam & EO preferred)
- Deep expertise in: Reprocessing, cleaning, and disinfection validation
- Strong working knowledge of FDA, ISO, and USP frameworks
- Demonstrated experience as a technical authority influencing senior technical professionals
Nice To Haves
- Experience in contract testing or services environment
- Experience defining technical standards across multiple teams or sites
- Experience supporting regulatory submissions and audits
Responsibilities
- Ensure consistent testing methods, data interpretation, and reporting
- Reduce variability across teams
- Support troubleshooting and continuous improvement
- Translate FDA, ISO, and USP requirements into clear actions
- Anticipate industry changes and adapt technical strategies
- Support growth areas like sterilization, cleaning, and disinfection
- Build and develop SME capabilities
- Define skill expectations and training priorities
- Reduce reliance on single experts
- Serve as the escalation point for complex technical issues
- Provide clear, binding technical decisions
Benefits
- Comprehensive medical coverage
- Dental options
- Vision options
- Life insurance
- Disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
