Job Information
Atricure, Inc. Senior Design Assurance Quality Engineer in Cincinnati, Ohio
Senior Design Assurance Quality Engineer Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA Req #2148 Tuesday, July 9, 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 will be part of one or more product development teams where they will responsible for contributing to the on-time development of high-quality products. This position will also be responsible for supporting and leading activities related to trending quality field performance. This will position will be responsible for subsequent improvements for marketed products and optimization of design control processes as needed. ESSENTIAL FUNCTIONS OF THE POSITION: On time quality delivery of assigned product development team deliverables Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations. Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities. Drive continuous improvements through observation, measurement and root cause analysis/resolution Develop new processes which support speed, cost reductions and quality improvements Provide subject matter expertise for assigned processes to users as necessary. Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions Provide guidance for development of manufacturing test/evaluation methods and process validation Provides investigative support/leadership for product quality issues Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity. Serve as technical resource for problem investigations to guide root cause analysis and corrective action development. Provide mentorship to junior level design assurance engineers in design control and product development Ensure commitment to functional excellence and the ability to execute positive changes ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree in Engineering required or demonstrat