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.