Director of Endoscopy Reprocessing, Infection Control

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee reprocessing and infection control initiatives related to the endoscopic product range.

• Act as the primary resource and subject matter expert for cleaning, high-level disinfection, and sterilization processes for Fujifilm endoscopy products.

• Collaborate with headquarters, customers, third-party organizations, sales teams, field personnel, international representatives, and marketing/R&D teams based in Japan.

• Create or assist in validation programs for endoscope designs and reprocessing protocols.

• Support FDA requests and comply with requirements, including 522 Postmarket Surveillance Studies and Human Factors Testing.

• Develop and update endoscope operation manuals, reprocessing guidelines, and product labeling.

• Formulate policies, policy statements, and notifications for customers and sales representatives concerning infection control and reprocessing.

• Provide education and insights on infection control and reprocessing topics.

• Establish educational resources and review training materials.

• Assist sales management and Product Management with the development and maintenance of key U.S. target markets through luminary customer engagement.

• Represent the company in national committees and at meetings and seminars that establish reprocessing guidelines.

• Monitor and relay new trends and guidelines in reprocessing and infection control to Fujifilm Tokyo.

• Collaborate with AER and sterilizer OEMs to validate and broaden reprocessing alternatives.

• Oversee the HCUS Clinical Education Manager responsible for reprocessing training.

• Adhere to FDA, ISO, legal, regulatory, and applicable standards requirements.

• Travel 30–50% based on business requirements.

⛳️ Requirements

• A Bachelor’s degree in biology or microbiology is mandatory.

• At least 10–12 years of experience in medical device reprocessing, validation studies, and best practices in infection control.

• Strong expertise with flexible endoscopes.

• Comprehensive knowledge of cleaning and reprocessing medical devices.

• Experience working with the FDA is essential.

• Familiarity with biological evaluation of medical devices and biocompatibility.

• Ability to work both independently and within a close-knit team.

• Outstanding communication, interpersonal, analytical, and problem-solving capabilities.

• Proficient in computer applications such as Word, Excel, and PowerPoint.

• Effective time management abilities.

• High level of knowledge and literacy in endoscopic applications.

• Strong analytical and critical thinking skills.

• Ability to read, analyze, and interpret essential job-related documents.

• Skillful in presenting and communicating effectively and professionally to both internal and external clients.

• Capable of meeting physical demands, including standing, walking, using a keyboard, reaching, balancing, stooping, kneeling, crouching, talking, and hearing.

• Ability to occasionally lift and/or move up to 30 lbs.

• Specific vision abilities, including close, distance, color, and depth perception, as well as focus adjustment.

• 3–5 years of experience as an accredited microbiologist is preferred.

• A Master’s degree is preferred.

• Willingness to travel 30–50% based on business needs.

• Compliance with applicable facility vendor credentialing and vaccination requirements where necessary.

🏝️ Benefits

• A dynamic and flexible work environment.

• Equal opportunities in hiring, promotions, compensation, benefits, and training.

• Reasonable accommodations during the application, interview, testing, and selection processes.

• Company-mandated vaccination/testing and face covering policies as applicable, with legally required accommodations.