Principal Mechanical Engineer

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 and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on

POSITION SUMMARY:

This position will work on project teams to design, build and test next generation radiofrequency (RF) catheter devices that are used by electrophysiologists and cardiac surgeons.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Lead the technical development and implementation of RF catheter devices that meet out customers' needs, comply with regulatory requirements, and deliver value to the business
• Develop product performance requirements as well as assembly and component specifications including the integration and consideration of applicable standards and regulations
• Perform a variety of engineering design and development tasks, to include design, analysis, material selection, prototyping, in-vivo and in-vitro testing, and user validation
• Select appropriate method of analytical modeling/ analysis of new technologies in support of achieving product performance requirements.
• Develop and validate test methods for new product features and functions
• Define methods and develop processes for assembly of new products
• Obtain input/ feedback from key customers - surgeons, nurses, and other clinicians
• Establish understanding of clinical procedures and techniques applicable to AtriCure products
• Create and maintain concise technical documentation
• Generate individual work plans, and coordinate activities with product development teams
• Communicate with and direct external suppliers of components subassemblies and finished assemblies
• Generate/ document engineering design changes
• Design, develop, and test all aspects of medical components, equipment, and instruments
• Perform analysis related to the design, development, and implementation of catheter instruments for products
• Lead technical development efforts, specifically the design of medical devices, material assessment and selection, testing and analysis, verification and validation
• Generate new product concepts
• Generate and document intellectual property
• Lead complex tasks with minimal supervision or guidance
• Support the development of the overall AtriCure product portfolio including procedural needs and technology solution definition
• Establish a personal plan for prioritization of effort, definition of measurable goals, and planning of activities
• Mentor more junior engineers or co-op students

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
• Position will involve working in a lab environment with tissue

BASIC QUALIFICATIONS:

• Bachelor's degree required in Mechanical or Materials Engineering or demonstrated equivalent combination of education, training and experience
• 10+ years of experience in catheter-based medical device product development or equivalent field
• Requires solid understanding of:

• Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
• External Standards, Quality controls and Manufacturing methods
• Complete development life cycle including needs assessment, Voice of the Customer, technology development, detail design and manufacturing systems development, regulatory requirements, and product verification/validation.
• Development protocol/ report writing with statistically sound rationale
• Test method development and validation

• Requires track record of:

• Creative problem solving
• Analytical approach to implementation
• Assembly / manufacturing process assessment and development in catheter-based medical products.
• Prioritizing tasks and generating a timely schedule of completion
• Identifying user needs and generating solutions
• Determining appropriate method for data analysis, troubleshooting, and formal root-cause analysis
• Manager broad range of tasks while providing direction to more junior engineers
• Generating and documenting intellectual property
• Must be proficient acting in integrated process teams, as well as coordinating and communicating customer requirements

• Excellent written and oral communication skills
• Understanding of program management tools and expectations of medical device design and manufacturing controls
• Experience working in team environment
• Ability to read and generate technical specifications, blueprints, and drawings.
• Experience with International Usability Standards and the practical application of Usability Engineering
• Ability to travel 20%

PREFERRED QUALIFICATIONS:

• MS degree in Mechanical Engineering
• 15+ years of experience in catheter-based engineering or equivalent field
• Expert-level statistics-based data analysis, problem-solving and troubleshooting
• Track record of detailed technical project management exhibiting comprehensive planning and thorough communication; preferred experience using MS Project as a planning tool
• Excellent understanding of industry regulations as it pertains to medical devices
• Excellent understanding of external standards, design controls, quality controls, manufacturing methods
• Experience in PMA and 510k device development
• 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

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).

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

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, 15 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: