AtriCure, Inc. is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
POSITION SUMMARY:
The Senior Software/Systems Engineer contributes to the company’s success through the design and development of software on capital equipment and devices. This position reports to the Sr. Engineering Project Manager in the Ablation Franchise. The individual will work on capital equipment projects to develop and test software for instrumentation 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 Senior Software/Systems Engineer may work independently on projects with broad scope, or be a team member on PD project.
ROLES AND RESPONSIBILITIES:
Subject Matter Expert for software for Product Development.
Coordinate software development tasks to include design, integration, and formal testing of capital equipment and devices.
Develop and complete actions in software specifications, technical and logistical requirements, and other disciplines.
Implement and test advanced software security techniques.
Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products.
Create and maintain programmatic and technical documentation to insure 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 software components in capital equipment and machinery.
Generate and document intellectual property.
Perform a variety of complex engineering design and development tasks, to include design, testing and analysis, verification, and validation.
Develop software test methods.
Review and authorize engineering design changes.
Develop software specifications including the integration and consideration of applicable standards and regulations.
May mentor junior engineers.
BASIC QUALIFICATIONS:
BS in Engineering. Systems Engineering, Electrical Engineering or software engineering degree.
7+ years of experience in systems engineering, electrical, software or equivalent field.
Demonstrated skills in Electrical engineering, including software.
Ability to design and implement software of embedded devices and systems
Experience in hardware/software development methodologies and structured approaches to software development and deployment.
Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating customer requirements.
Demonstrated understanding of software and electrical 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, ISO 13485 and ISO 62304.
Ability to read technical specifications, blueprints, and drawings.
Capable of prioritizing tasks and provide a timely schedule of completion.
Capable of sub-assembly level software analysis (not limited to circuit, tolerance or finite element analysis).
Demonstrated proficiencies of communicating software best practices.
Experience with International Usability Standards and the practical application of Usability Engineering.
PREFERRED QUALIFICATIONS:
MS degree in Systems Engineering, Electrical Engineering, or Software Engineering.
10+ years of experience in Systems Engineering, Electrical Engineering, Software Engineering or equivalent field.
Excellent demonstrated skills in software and electrical engineering.
Vast Experience in software development methodologies and structured approaches to software/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 and documenting intellectual property.
Ability to generate technical specifications, blueprints, and drawings.
Experience with Human Factors for medical devices/equipment.
ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):
This position is in an office / lab environment.
Position involves periods of working at a desk / on a computer for extended times.
Position will involve working in a lab environment with tissue.
Position will involve approximately 20% travel
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