Director, Cleaning, Disinfection & Sterilization

Company: Karl Storz Endovision Inc
Location: Charlton
Posted on: January 26, 2023

Job Description:

Company Overview

KSE specializes in production and servicing of minimally invasive flexible endoscopes, with legacy devices based on fiber optic technology, and next generation devices designed around the latest video technologies. The main campus is located in Charlton MA, with an Advanced Machining Center and SSU cleanroom located in Franklin MA. The distribution facility for all US devices is located in Auburn, MA. There are two additional subsidiaries in the US for operations - a camera and CCU facility located in Goleta CA, and an Operating Room design and installation team located in Houston Texas. Our culture is built on a foundation of respect for people and continuous improvement, consistent with organizations following a lean philosophy. Speed, flexibility, and collaboration are at the heart of the operating system, geared toward providing the best value products to hospitals, clinics, and physician's offices all over the world. Significant emphasis is placed on creating and building a culture of diversity, equity, and inclusion, and creating a safe environment where people can come to work and contribute to their fullest potential.

Role Overview

The ideal candidate is skilled in collaborative leadership and has successfully managed design and process validation and verification testing for cleaning, disinfection, and sterilization (CDS) to support FDA Class II device 510k submissions and/or Class III device PMA submissions. The candidate will have experience with market surveillance and complaint management investigation for issues relating to CDS. Finally, they will have experience in effectively supporting and working within cross functional teams in bringing sterile single use (SSU) devices to market.

This role will coach a team of 5 specialists and technicians in conducting screening/feasibility experiments, while managing relationships with manufacturers of CDS equipment deemed compatible with our devices. They will also manage the external contracting of tests used for design verification and for root cause investigations for issues and problems relating to CDS. Our devices include equipment manufactured in the US, imported from Germany, manufactured by KARL STORZ, and 3rd party devices purchased for sales in the US. This role will frequently interface with the Regulatory, Sterilization, Biocompatibility team located in Germany, as well as the Regulatory Affairs Team based in the US, the Global R&D team, Product Management based in Germany, and US operations.

Key Responsibilities

* Ensures 510k/PMA design validation and verification testing and documents supporting CDS claims are complete, and fact based for devices legally marketed in the US


* Creates and executes appropriate and efficient pre-clinical safety testing based on US standards


* Determines US regulatory requirements for new/proposed products in biocompatibility (in collaboration with RSB in Germany)


* Troubleshoots complaints and problems relating to cleaning and/or sterilization of devices marketed in the US. Drives to root cause and ensures effective countermeasures are implemented.
* Leads and manages the creation, approval, and maintenance of reprocessing testing documentation for US marketed medical devices.
* Stays current with emerging technologies and regulation pertaining to reprocessing and to SSU devices.
* Communicates with US and Canadian regulatory agencies as required to advance product approvals and submission determination of medical devices, working closely with US RA.
* Ensures AAMI recommendations are assessed against KS US based policies and procedures and deployed as appropriate.
* Ensures qualified test houses used for KS are audited on a periodic basis and maintain appropriate certifications.
* Works with operations to ensure that appropriate process controls are in place to support successful cleaning, disinfection, sterilization, and biocompatibility requirements from a production perspective.

Key Requirements

* Bachelor of Science in Toxicology, Biology, Chemistry, Chemical Engineering, or Material Science required. Advanced degree desirable
* 12+ years relevant experience in reprocessing technologies.
* Experience bringing SSU devices to market in the US
* Knowledgeable with the Code of Federal Regulation pertaining to medical devices, in particular regulations and standard for cleaning, disinfection, sterilization, and biocompatibility (toxicology)assessments.
* Knowledgeable with EN ISO 13485 standards, with ST91 and additional relevant guidance documents
* Humble inquiry leadership skills and ability to coach and develop others.
* Strategic thinker able to bring together competing points of view and create a path forward
* Demonstrates data driven and fact-based approaches
* Certifications in toxicology or biocompatibility desirable
* Able to effectively communicate with notified bodies and with the FDA.
* Excellent skills with Microsoft products - Word, Excel, PowerPoint. Advanced use of Excel for data analytics required.

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Keywords: Karl Storz Endovision Inc, Worcester , Director, Cleaning, Disinfection & Sterilization, Executive , Charlton, Massachusetts