Job Information
Atricure, Inc. Product Sterilization Scientist in Cincinnati, Ohio
Product Sterilization Scientist Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA Req #2144 Thursday, June 27, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: This position is responsible for supporting the ethylene oxide (EO) product sterility assurance program by providing technical and scientific expertise to other Sterilization and Environmental Monitoring(SEM) staff and internal AtriCure's customers. The incumbent functions with limited supervision, in a GMP-compliant fashion, to support new product development as well as the current portfolio of marketed products sterilized by ethylene oxide gas. The position occasionally supports the related technical disciplines of environmental monitoring and gamma radiation sterilization, and actively participates in a variety of department-specific and site-level quality systems (QS) and quality assurance (QA) activities. The successful candidate must possess a broad array of diverse technical and scientific skills and subject matter knowledge, the ability to quickly identify and adjust to changing priorities, and the willingness and confidence to serve as the lead EO subject matter expert (SME). ESSENTIAL FUNCTIONS OF THE POSITION: Serve as primary reviewer of 3rd party laboratory and sterilization service provider reports for EO-sterilized products Administer the routine EO-sterilized product bioburden analysis program Write and/or review and disposition product bioburden data and reports Prepare and analyze associated data trends and communicate results to management and affected disciplines (engineering, PD, Operations, etc.) Lead cycle development, qualification, requalification activities and product-specific sterilization validations and adoptions Provide front-end sterilization technology consultative services to product development teams; assist with scheduling, budget estimates, deliverables as needed to ensure product and project launch success and compliance with applicable regulations, industry standards, and AtriCure business objectives Support Regulatory Affairs with the sterilization-related aspects of national and international marketing submissions Develop and maintain the Product Sterilization Master File (PSMF) for EO-sterilized products Perform and document periodic reviews of product-related changes and determine impact on current sterilization family groups and sterilization cycles Perform and document periodic reviews of sterilization cycles and sterility results to confirm compliance with validated cycle parameters and load patterns Ensure product testing services performed by 3rd party service providers comply with applicable regulation