AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

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. Job performance requires application of technical abilities, knowledge of life/medical sciences, healthcare practices and procedures, and an understanding of product development methodologies. Deliverable outputs include design, analysis, bench, in-vitro, and in-vivo testing, production transfer, and documentation of products that meet medical and regulatory guidelines. Most work will be performed in the context of multi-disciplinary teams and under the direction of a senior engineer or project manager.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Design, develop, analyze, and test medical devices using various test equipment, and instruments
• Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
• Build prototypes using various rapid prototyping methods to test design concepts
• Use scientific principles to test performance of medical devices. Record data using appropriate tools and analyze with statistical rigor. Develop conclusions, and present recommendations in written and verbal communications
• 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.
• Conduct clinical laboratory activities related to new product development, including animal research studies and procedure development
• Provide analysis, testing, and reporting to predict and verify the human body response to designed devices
• Contribute to improvement in methods and processes of the product development organization
• Generate and document intellectual property

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance
• 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
• 3 years of experience in biomedical engineering or equivalent field
• Solid understanding of:
1. o Anatomy, physiology, and biophysics
2. o In-vitro and in-vivo lab activities
3. o Medical device design
4. o Clinical procedure development
5. o Language of medicine
• Familiarity with:
1. o Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
2. o External Standards, Design controls, Quality controls, Manufacturing methods
• A track record of:

• Creative problem solving
• Prioritizing tasks and producing deliverables per schedule expectations
• Conducting and reporting laboratory and animal research studies
• Completion of significant and broad tasks with limited direct supervision
• Demonstrated proficiencies of communicating 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 Engineering
• MS in Engineering or Life Sciences discipline
• 5 years of experience in biomedical engineering or equivalent field
• 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 required
• Ability to occasionally bend and push/pull
• Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
• Ability to pass pre-employment drug screen and background check

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