Senior Research and Development 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 research and development of the next generation of AtriCure products including RF, Cryo and LAA management and potential adjacent therapies and technologies new to AtriCure. Beyond displaying knowledge of core engineering and scientific principles, this position requires excellent teamwork, communication, curiosity, and organizational skills to assist us in growing our business.

The person in this position will work within a project team environment to develop novel and/or next generation medical devices used by cardiologists, electrophysiologists, and cardiac surgeons. Responsibilities will include design planning, prototype design and build, design analysis, design documentation, test method development, risk management, design verification and validation leadership, usability validation, design transfer to manufacturing, as well as interaction with surgeons and VOC gathering. Most work will be performed in the context of multi-disciplinary teams and under the direction of the engineering manager or a project manager.

In addition to the above requirements, experience and knowledge of life/medical sciences, healthcare practices and procedures is preferred.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Aid in the design and development of novel RF/Cryo ablation devices and LAA management devices including ownership of assigned subsystems or components
• Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
• Collect, organize, and interpret design inputs including voice of customer (VOC) and voice of business
• Participate in the development of product specifications and requirements documents, ensuring traceability and alignment with user needs
• Design and build prototypes using various rapid prototyping methods to test design concepts
• Create and review 3D CAD part files, assemblies, and associated drawings including interpretation of GD&T and tolerance analysis.
• Interface with suppliers to develop processes, optimize component design, and support manufacturability
• Perform structural, fatigue, and thermal analysis for complex medical device components, subassemblies, assemblies, and systems.
• Ability to perform geometric tolerancing analysis and provide design recommendations
• Provide design feasibility recommendations based on material selection , processes, and functional requirements
• Use scientific and engineering principles to test device performance. Record, analyze, and interpret data using appropriate statistical tools.. Develop conclusions and clearly communicate findings
• Troubleshoot new designs and/or develop reliability improvements for existing designs
• Develop and validate test methods, including fixtures and protocols, for characterization, verification, and validation activities
• Provide testing, analysis, and reporting to predict and verify the human body interactions with designed devices
• Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design related risks are identified and appropriately mitigated
• Conduct clinical laboratory activities related to new product development, including animal research studies and procedure development
• Be knowledgeable of surgical techniques, devices and procedures and be comfortable using them in a preclinical lab setting.
• Work with Key Opinion leaders to collect Voice of Customer data and develop and identify product requirements.
• Generate and document intellectual property

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 required in Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training, and experience
• 5+ years of experience in similar role.
• Solid understanding of:

• Anatomy, physiology, and biophysics
• In-vitro and in-vivo lab activities
• Medical device design and prototyping
• External Standards, Design controls, Quality controls, Manufacturing methods
• Clinical procedure development
• Language of medicine

• Familiarity with:

• Design Controls and FDA QSR 21 CFR Part 820
• ISO 13485 and ISO14971

• A track record of:

• Creative and structured problem solving
• Prioritizing tasks and producing deliverables per schedule expectations
• Conducting and reporting laboratory and animal research studies
• Completion of significant technical and broad tasks with limited direct supervision
• Demonstrated proficiencies of communicating engineering best practices

• Understanding of development life cycle including needs assessment, drafting product requirements, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation
• Proficiency acting in integrated process/product teams, as well as coordinating and communicating customer requirements
• Excellent written and oral communication skills
• Experience and success working in team environment
• Experience with data analysis, problem-solving, and troubleshooting
• Experience with International Usability Standards and the practical application of Usability Engineering
• Ability to read technical specifications, blueprints, and drawings

• Ability to travel 10%

PREFERRED QUALIFICATIONS:

• BS in Biomedical or Mechanical Engineering
• MS in Mechanical Engineering or Life Sciences discipline
• Strong knowledge in DFM of molded, machined, and thermoformed components
• Experience with plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding
• Practical working experience with Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack analysis
• Advanced in SolidWorks 3D modeling, standard analysis tools and methodologies
• Excellent demonstrated ability with data analysis, problem-solving, and troubleshooting
• Track record of managing technical development tasks exhibiting comprehensive planning and thorough communication
• 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

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).