Director of Endoscopy Reprocessing and Infection Control

About the role

This position is responsible for the management of reprocessing and infection control activities associated with the endoscopic product portfolio. The Director of Endoscopy Infection Control serves as the primary company resource and subject matter expert for the Endoscopy Division regarding the cleaning, high-level disinfection, and/or sterilization of Fujifilm endoscopy products. This role works cross-functionally with customers, third-party companies, and internal stakeholders—including sales/sales management, field personnel, international liaisons, and marketing/R&D groups in Japan—to ensure Fujifilm reprocessing recommendations meet U.S. market needs and comply with industry infection control guidelines.

Responsibilities

• Collaborate with headquarters liaisons and teams to communicate subsidiary needs and U.S. requirements for reprocessing and infection control issues.
• Develop and/or support validation programs for testing endoscope designs and reprocessing instructions, working with Fujifilm Tokyo and independent microbiology laboratories as needed.
• Partner with Fujifilm Japan to support FDA requests and requirements, including 522 Postmarket Surveillance Studies and Human Factors Testing of Fujifilm products.
• Serve as technical writer/reviewer to develop and/or revise endoscope operation and reprocessing manuals based on the latest industry guidelines; review and improve product labeling for accuracy, consistency, and ease of understanding.
• Review operation manuals for any reprocessing-related comments or instructions.
• Develop policies, policy statements, customer notifications, and sales representative communications regarding infection control and reprocessing issues.
• Act as a senior corporate source of education and information on infection control and reprocessing issues.
• Establish educational tools and review training aids (such as quick reference guides and slide presentations) on reprocessing and infection control practices.
• Assist sales management and Product Management in developing and maintaining luminary customers in key U.S. target markets.
• Represent the company on national committees and at meetings or seminars developing reprocessing guidelines.
• Keep Fujifilm Tokyo informed of new reprocessing and infection control trends and guidelines.
• Work with third-party companies, including AER and sterilizer OEMs, to validate and expand reprocessing options for Fujifilm endoscopes.
• Oversee and manage the HCUS Clinical Education Manager responsible for reprocessing training of HCUS personnel and customer in-services.
• Comply with all applicable U.S. FDA medical device regulatory requirements, ISO standards, and other relevant laws, regulations, and standards.

Requirements

• Bachelor’s degree in biology or microbiology (required). A Master’s degree is preferred.
• Minimum of 10–12 years of experience in medical device reprocessing (cleaning, disinfection, and sterilization), validation studies, and infection control best practices, including a strong background in flexible endoscopes.
• 3–5 years of experience as an accredited microbiologist (preferred).
• Extensive knowledge of medical device cleaning and reprocessing.
• Background or experience working with the FDA and knowledge of the biological evaluation of medical devices (biocompatibility).
• Highly focused and results-oriented; able to identify goals and priorities and resolve issues early.
• Demonstrated ability to work independently and in a team environment; self-starter who can motivate others.
• Exceptional communication, interpersonal, analytical, and problem-solving skills.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Strong time management skills.
• High command and literacy in endoscopic applications.
• Strong analytical and critical thinking skills.
• Ability to read, analyze, and interpret essential job-related documents.
• Ability to present and speak effectively and professionally to internal and external customers.

Physical Requirements

• Frequently required to stand, walk, use hands to finger, handle, or feel objects, use a keyboard, reach with hands and arms, balance, stoop, kneel, crouch, and talk or hear.
• Occasionally lift and/or move up to 30 lbs.
• Specific vision abilities required include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.

Travel

30–50% travel depending on business needs.