Position Overview

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 is the primary company resource and subject matter expert for the Endoscopy Division as it relates to 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 that the Fujifilm reprocessing recommendations satisfy US market needs and comply with industry infection control guidelines.

Job Description

Duties and Responsibilities:

• Collaborate with headquarter liaisons and teams to effectively communicate subsidiary needs and US requirements for reprocessing and infection control issues.
• Develop or/and support validation program for testing of endoscope designs and reprocessing instructions, working with Fujifilm Tokyo and independent microbiology laboratories as necessary.
• Partner with Fujifilm Japan to support FDA requests and requirements including 522 Postmarket Surveillance Studies and Human Factors Testing of Fujifilm products, as necessary.
• Serve as technical writer/reviewer to develop and/or revise endoscope operation and reprocessing manuals based upon latest industry guidelines and review/improve product labeling for accuracy, consistency and ease of understanding. Review operation manuals for any comments/instructions related to reprocessing.
• Develop policies, policy statements, customer, and sales rep notifications regarding infection control/reprocessing issues.
• Serve as a senior corporate source of education & information for infection control/reprocessing issues.
• Establish educational tools and review training aids (such as QRGs, slide presentations) on reprocessing and infection control practices.
• Assist sales management and Product Management with development and maintenance of luminary customers in key target markets in US.
• Represent the company on national committees and at meetings/seminars developing reprocessing guidelines. Keep Fujifilm Tokyo well informed of any new reprocessing/infection control trends and/or guidelines.
• Have adaptable learning skills and an established track record of being a subject matter expert on reprocessing and infection control matters.
• Work with third-party companies including AER and sterilizer OEMs to validate and expand reprocessing options for Fujifilm endoscopes.
• Oversee/manage HCUS Clinical Education Manager responsible for reprocessing training of HCUS personnel and customer in-services.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO standard requirements and all other applicable laws, regulations, and standards.

Qualifications:

• Bachelor's degree in biology or microbiology is required. A Master's degree preferred.
• Minimum of 10-12 years' experience in medical device reprocessing, (cleaning, disinfection and sterilization) validation studies and infection control best practices including a strong background of flexible endoscopes.
• 3-5 years' experience as an accredited microbiologist is preferred.
• Extensive cleaning/reprocessing knowledge of medical devices is required.
• Background/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 in initial stages.
• Demonstrated ability to work independently and in a close team environment, self-starter who can motivate others.
• Possess exceptional communication/interpersonal, analytical, and problem-solving skills.
• Work remotely
• Proficient computer skills using Word, Excel, PowerPoint.
• Effective Time Management skills.
• High command and literacy in endoscopic application
• 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 all internal and external customers.

Physical requirements:

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• Frequently required to stand; walk; use hands to finger, handle or feel objects, ability to 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 by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.

Travel:

• 30-50% depending upon business needs.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements.

For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.