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.
This position will lead or work on project teams to plan and support projects including the design, build, and test of next generation medical devices or significant improvements to existing products that are used by cardiac surgeons and electrophysiologists.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Work in a cooperative cross functional team environment to accomplish personal and team goals and objectives associated with development of innovative medical devices or innovative improvements to existing devices.
- Support and lead the technical development efforts of medical device projects including mechanical design, testing, analysis, verification, and validation
- Develop component and product technical specifications including the integration and consideration of applicable standards and regulations
- Support the product development life cycle including needs assessment, Voice of the Customer, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation
- Develop an understanding of AtriCure devices with an eye for improvement and development projects.
- Generate work plans, and coordinate activities with product development teams
- Operate program management tools and documentation requirements of Medical Device Design Controls
- Perform Analytical modeling / analysis of new technologies in support of achieving product performance requirements
- Communicate with external suppliers of components, subassemblies and finished assemblies
- Generate and document intellectual property submissions
- Understand and practice GD&T and how to properly apply it to yield the desired fits between joining parts.
- Expertise in computer communication tools, ability to manage design research / development activities through the product life cycle, computer aided engineering tools (Solidworks, FEA software), scheduling (Microsoft project), project documentation, statistics and intellectual property generation.
- Perform mechanical analysis including Statics and Dynamics, Finite Element Modeling, and Material Properties
- Establish understanding of clinical procedures and techniques applicable to AtriCure products
- Develop and validate test methods
- Has a knowledge of manufacturing methods and capabilities including plastic injection molding, metal stamping, and metal machining, casting, stamping, forming, grinding, etc.
- Lead tasks with minimal supervision or guidance
- Work independently applying comprehensive and diverse engineering principles and practices to broad assignments, including independently leading a moderate project
- Prioritize tasks and provide a timely schedule of completion
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
- Bachelor’s degree required in Engineering or demonstrated equivalent combination of education, training and experience
- 5+ years of experience in mechanical engineering in medical device product development or equivalent field
- Must be confident, goal oriented, self-motivated and a team player
- Must have strong and proven relationship building skills
- Proven track record of significant technical achievement, capability, and contribution to the success of the business
- Ability to lead project activity, mentor others, and lead company technical initiatives
- Experience developing inspection/testing requirements and techniques
- Data analysis, problem-solving, troubleshooting and formal root-cause analysis experience
- Proficient acting in integrated process teams, as well as coordinating and communicating customer requirements
- CAD experience
- Excellent written and oral communication skills, including scientific/technical report writing skills
- Ability to read technical specifications, blueprints and drawings
- Engineering/design background
- Knowledge of product design, prototyping, and development methodologies, as well as an understanding of healthcare practices and procedures.
- Track record of generating and documenting intellectual property
- Solid understanding of industry regulations as it pertains to medical devices, external standards, design controls, quality controls, and manufacturing methods.
- Demonstrated understanding of the design of medical devices including: design, testing and analysis, verification, and validation
- Experience in the area of FDA and Regulatory requirements and Standards is required.
- Proficient knowledge in risk management tools such as FMEAs
- Demonstrated understanding of test method development
- Able to work independently on broad tasks and minimal supervision
- Must be a hands-on, creative problem solver with solid trouble-shooting skills
- Ability to travel 10%
- Experience in the design and development of disposable medical devices
- Record of detailed project management exhibiting comprehensive planning and thorough communication; preferred experience using MS Project as a planning tool
- Computer networking experience
- Domestic and international regulatory experience
- Expertise in statistical analysis and techniques
- Understanding of program management tools and expectations of Medical Device Design and manufacturing controls.
- Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, etc.
- Computer experience with Microsoft programs such as Project, PowerPoint, Outlook, Excel, and Word
- 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 25 pounds
- Ability to pass pre-employment drug screen and background check
AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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 https://www.e-verify.gov/
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: https://www.atricure.com/benefits