Principal Scientist- Med Device Mircobiology

Key Responsibilities
Serve as a technical subject matter expert and resource for internal and external audits, client interactions, and business development activities.
Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs.
Support method development, validation, troubleshooting, and continuous improvement initiatives.
Communicate complex technical information effectively to clients, regulatory bodies, and internal stakeholders.
Core Competencies
Exceptional collaboration and interpersonal skills, with the ability to build strong partnerships and work effectively across cross-functional teams.
Strong analytical, problem-solving, and decision-making abilities.
Ability to influence stakeholders and provide technical leadership in a fast-paced, regulated environment.
Required Experience
Extensive experience in medical device reprocessing, including cleaning, disinfection, and sterilization processes.
Strong background in microbiological testing, including antimicrobial efficacy, sterility, sub-visible particle analysis, bioburden, microbial limits testing (MLT), container closure integrity testing (CCIT), and endotoxin testing, with recognized subject matter expertise in at least one testing discipline.
Experience working in controlled environments and cleanroom operations.
Comprehensive understanding of the medical device lifecycle, from development through commercialization and post-market support.
Demonstrated expertise in designing, executing, and evaluating scientific studies and test methods.
Proven ability to interpret pharmacopeial requirements, industry standards, and regulatory guidance documents, and assess emerging methodologies and technologies for applicability.
Strong technical writing skills with experience authoring protocols, reports, investigations, and other scientific documentation.
Minimum Qualifications
Bachelor’s degree in biology or microbiology
Minimum 5 years of laboratory experience
Working knowledge of Electronic Lab Notebook (ELN), Lab Information Management System (LIMS)
Solid familiarity and experience with regulatory and accreditation standards (GMP, GLP, USP, ISO, AATCC, etc).
Prior experience working in microbiology – especially antimicrobial and reprocessing
Strong leadership
Excellent planning, organizational, and multitasking skills.
Strong technical writing skills including experience with investigations.
Familiarity with Lean, Six Sigma, or similar process improvement methodologies
Experience with onboarding new instrumentation, including performing/reviewing IQ/OQ/PQ data or qualifications
Authorization to work in the US indefinitely without restriction or sponsorship

Employment type
Full-time

Work arrangement
No