Principal Systems Engineer

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 contribute to the company success through the design and development of capital equipment and devices. This position will report to the Senior Director, Research and Development in our Ablation Franchise. The individual will work on capital equipment projects to design, build, and test next generation capital equipment that is used by cardiac surgeons and electrophysiologists. This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-lead products through positive patient outcomes. The Principal Systems Engineer may work independently on projects with broad scope or be a team member on PD project. ESSENTIAL FUNCTIONS OF THE POSITION: Define and lead system development tasks to include design, integration, and formal testing of capital equipment and devices Develop and complete actions in system specifications, technical and logistical requirements, and other disciplines Identify and develop a rapport with key customers – surgeons, nurses, and other clinicians Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products Create and maintain programmatic and technical documentation to ensure efficient planning and execution Aligns and coordinates resources, priorities, work plans, and activities among outside suppliers and the AtriCure Product Development group Determines work procedures, prepares work schedules, and expedites workflow Design, develop and test all aspects of electrical components, equipment and machinery Communicate with and direct external suppliers of components, subassemblies and finished assemblies. Generate and document intellectual property Develop and perform stress and performance tests on a variety of electrical/electronic system hardware including circuit boards, processors and wiring Perform a variety of complex engineering design and development tasks, to include design, testing and analysis, verification, and validation Develop and validate test methods Review and authorize engineering design changes Develop component and product technical specifications including the integration and consideration of applicable standards and regulations Mentor junior engineers 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 judgement Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: BS in Engineering 15+ years of experience in systems engineering or equivalent field Demonstrated skills in System engineering Experience in hardware/software development methodologies and structured approaches to system development Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating customer requirements Demonstrated understanding of circuits and circuit design Understanding of program management tools and expectations of medical device design and manufacturing controls Experience working with customers and translating the “Voice of the Customer” into technical specifications Demonstrated understanding of protocol/report writing Experience with data analysis, problem-solving, and troubleshooting Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485 Ability to read technical specifications, blueprints, and drawings Capable of prioritizing tasks and provide a timely schedule of completion Capable of sub-assembly level analysis (not limited to circuit, tolerance or finite element analysis) Demonstrated proficiencies of communicating best practices Experience with International Usability Standards and the practical application of Usability Engineering Ability to travel 25% PREFERRED QUALIFICATIONS: MS degree in Systems Engineering or Electrical Engineering Excellent demonstrated skills in System engineering Vast Experience in hardware/software development methodologies and structured approaches to system development Demonstrated proficiency in leading integrated process teams, as well as coordinating and communicating customer requirements Excellent written and oral communication skills Excellent understanding of industry regulations as it pertains to medical devices Excellent understanding of external standards, design controls, quality controls, manufacturing methods Proven track record of generating an