Principal 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 work on project teams to design, build and test next generation radiofrequency and cryo ablation devices that are used by cardiac surgeons and electrophysiologists.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Lead the technical development and implementation of medical device design that the customers' needs, comply with quality and regulatory requirements, and deliver value on business objectives
• Develop and manage system/subsystem level requirements including definition, analysis, and traceability management to ensure clear, unambiguous, and testable design specifications.
• Strong understanding of applicable standards and regulations and their application during the product development process
• Perform analysis to evaluate technical feasibility including FEA, Push-Pull dynamic testing, written calculations, and statistical modeling
• 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
• Use Geometric dimensioning and tolerancing (GD&T) to define and communicate the nominal geometry and tis allowable variation on engineering drawings and models.
• 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/ surgical components, equipment, and instruments
• 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 Biomedical, Electrical, Mechanical or Materials Engineering or demonstrated equivalent combination of education, training and experience

• 10+years of experience in 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 lifecycle development; including needs assessment, Voice of the Customer, technology development, detail design and manufacturing systems development, system/subsystem level requirements, regulatory requirements, and product verification/validation

• Analysis by computer simulated programs and written calculations

• Familiarity with (push-pull) testing

• Materials analysis and selection, both polymers and metals

• 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

• 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 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 Engineering
• 15+years of experience in mechanical engineering or equivalent field
• Expert-level mechanical analysis, statistics-based data analysis, problem-solving and troubleshooting
• Proficiency in embedded system design, including microcontroller/microprocessor selection, firmware development (C/C++).
• Electromagnetic Compatibility (EMC/EMI): Knowledge of EMC/EMI principles and experience in designing for compliance with relevant medical device standards (e.g., IEC 60601-1-2).
• Safety & Compliance: Understanding of electrical safety standards for medical devices (e.g., IEC 60601-1) and their application in design.
• Troubleshooting & Debugging: Strong skills in electrical troubleshooting and debugging using oscilloscopes, multimeters, logic analyzers, and other test equipment.
• 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
• 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

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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: . 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 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).