Principal Scientist- Med Device Mircobiology
Core
Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs, serving as a technical subject matter expert for audits and client interactions.
Role type
Principal Scientist (Medical Device Microbiology)
Builds
Medical device reprocessing and microbiology testing programs
Domain
Medical Devices / Microbiology / Regulatory Compliance
Required skills
Medical device reprocessing expertise, Microbiological testing (antimicrobial efficacy, sterility, bioburden, MLT, CCIT, endotoxin), Cleanroom operations, Regulatory standards interpretation (GMP, GLP, USP, ISO), Scientific study design, Technical writing, Process improvement (Lean, Six Sigma), Instrument qualification (IQ/OQ/PQ)
Preferred skills
None stated
Technologies
ELN, LIMS
Responsibilities
Serve as technical subject matter expert for internal and external audits and client interactions, Provide scientific leadership on reprocessing and microbiology testing programs, Support method development, validation, and troubleshooting, Communicate complex technical information to clients and regulatory bodies
Seniority
Principal, hands-on IC with strategic guidance