Senior Biomedical 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 development of ablation products that treat atrial fibrillation, Left Atrial Appendage (LAA) Exclusion System products, and/or CryoNB products. Job performance requires application of technical abilities, command of life/medical sciences, healthcare practices and procedures, and a solid understanding of product development methodologies.  Deliverable outputs include analysis, design, evaluation, production transfer, and documentation of products that meet medical and regulatory guidelines. The Senior Biomedical Engineer will play a technical leadership role in the context of multi-disciplinary teams under the direction of a project manager.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Design, develop, analyze, and test medical/surgical components, equipment, and instruments
• Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
• Lead 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
• Define and execute improvement in methods and processes of the product development organization
• Mentor junior staff
• 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 Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training and experience
• 7 years of experience in biomedical engineering or equivalent field
• Solid understanding of:

• Anatomy, physiology, and biophysics
• Leading in-vitro and in-vivo lab activities
• Medical device design
• Data analysis with statistical methods
• External Standards, Design controls, and Quality controls

• Familiarity with:

• Design Controls standards FDA QSR 21 CFR Part 820 and ISO 13485
• Medical device manufacturing methods
• Cardiac and thoracic surgical procedures and terminology

• A track record of:

• Creative problem solving, prototyping, and troubleshooting
• Prioritizing tasks and producing deliverables per schedule expectations
• Leading teams to successful outcomes
• Leading and reporting laboratory and animal research studies
• Completion of significant and broad tasks with minimal supervision
• Understanding of development life cycle including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification/ validation
• Proficiency acting in and leading integrated process/product teams, as well as coordinating and communicating customer requirements
• Experience and dedication to mentoring more junior engineers
• Excellent written and oral communication skills
• Experience with International Usability Standards and the practical application of Usability Engineering
• Ability to read and create technical specifications, blueprints, and drawings
• Ability to travel 10%

PREFERRED QUALIFICATIONS:

• BS in Biomedical Engineering
• MS in Engineering or Life Sciences discipline
• 10 years of experience in biomedical engineering or equivalent field
• Experience in Materials Science
• 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
• Solid understanding of cardiac and thoracic surgical procedures and terminology
• Familiarity with project management methods and tools for planning, executing, and reporting results
• Experience in collaborating with Marketing and Sales disciplines, including establishing and maintaining customer relationships

OTHER REQUIREMENTS: 

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• 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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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, 20 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).