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
