Job Information
Atricure, Inc. Senior Product Sterilization Scientist in Mason, Ohio
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 AtriCure Sterilization Programs, specifically in gamma radiation and/or ethylene oxide modalities, by providing technical and scientific expertise to the Quality Operations staff and internal AtriCure customers. The Senior Sterilization Scientist works within the prescribed GMP/ISO Standards and ensures compliance to applicable domestic and international regulations. The Senior Sterilization Scientist is tasked with leading or supporting projects such as sterilization cycle/process development, management of sterilization cycle validations, product sterilization adoptions, change control assessments, improving sterilization and product microbiology programs and ensuring on-going sterilization effectiveness. This position will be responsible for sterility assurance for routine processing and managing product bioburden and endotoxin programs. ESSENTIAL FUNCTIONS OF THE POSITION: Apply knowledge of sterilization process and the associated microbiological concepts and practices for terminally sterilized single-use devices, as required to comply with relevant ISO standards, industry guidelines, and national / international regulations. Act as a sterilization and microbiology subject matter expert (SME), by supporting new product development, changes to existing commercial products, and associated domestic and international regulatory filings. Guide product development teams with scheduling, budget estimates, deliverables, as needed to ensure project and product launch success, and compliance with applicable regulations, industry standards, and AtriCure business objectives. Provide technical solutions to product development and engineering teams using various fields of science and sterilization theory and practice. Lead cycle development, validation, requalification activities, as well as product-specific sterilization qualifications and adoptions. Manage, perform and document periodic product reviews and annual cycle reviews to determine impact on current sterilization family groups and sterilization cycle effectiveness. Recommend actions to be taken, as needed, to maintain program effectiveness. Analyze/review chemical, biological, or microbiological results for raw materials, in-process materials, validation samples and product release test samples (includes, bioburden, organism, EO/ECH residual levels, BI testing, etc.). Perform product release activities, as required. Guide teams through effective sterilization impact assessments within change control activities. Mentor team for approach to assessment and deliverables to meet effective, and consistent practice aligning with internal pro