Reprocessing Scientist- Med Device Mircobiology

Technical subject matter expert and scientific lead for medical device reprocessing and microbiology testing programs, supporting audits, client interactions, business development, method development, and validation. Position is full-time, Monday to Friday 8:00am to 5:00pm, with additional hours as needed. Up to 25% travel may be required.

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

Requirements

Bachelor's degree in biology or microbiology; Minimum 5 years of laboratory experience; Working knowledge of Electronic Lab Notebook (ELN) and 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; 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; Strong technical writing skills with experience authoring protocols, reports, investigations, and other scientific documentation

Benefits

Comprehensive medical coverage, dental, and vision options; Life and disability insurance; 401(k) with company match; Paid vacation and holidays