AtriCure, Incis a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Position Summary:
The Mechanical Engineer contributes to the development of ablation products that treat atrial fibrillation. Job performance requires application of technical abilities, knowledge of mechanical engineering and materials science, and an understanding of product development methodologies. Deliverable outputs include analysis, design, evaluation, 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.
Roles and Responsibilities:
Design, develop, analyze, and test medical/surgical components, equipment, and instruments
Develop product performance requirements as well as assembly and component specifications
Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
Serve as a technical resource for materials science applications in product development
Conduct laboratory activities related to new product development, including in-vitro and in-vivo studies
Provide analysis, testing, and reporting to predict and verify the human body response to designed devices
BASIC QUALIFICATIONS:
BS in Mechanical Engineering or Materials Science
3 years of experience in mechanical engineering or similar field
Understanding of development life cycle including needs assessment, 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
A track record of:
Creative problem solving
Evaluating user needs and generating solutions
Prioritizing tasks and producing deliverables per schedule expectations
Completion of significant and broad tasks with limited direct supervision
Demonstrated proficiencies of communicating best practices
Experience and success working in team environment
Excellent written and oral communication skills
Experience with data analysis, problem-solving, troubleshooting, and formal root cause analysis
Experience in test method development and validation
Experience in execution of verification tests and generating test reports
Ability to read and create technical specifications, blueprints, and drawings
Familiarity with:
Materials Science as it pertains to medical device development
Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
External Standards, Design controls, Quality controls, Manufacturing methods
Statistical methods
PREFERRED QUALIFICATIONS:
MS in Mechanical Engineering or Materials Science
5 years of experience in mechanical engineering or similar field
Experience in mechanical engineering for medical device product development
Expertise in Materials Science for medical device development
Excellent demonstrated ability with statistics-based data analysis, problem-solving, and troubleshooting
Track record of managing technical development tasks exhibiting comprehensive planning and thorough communication
Excellent understanding of medical device industry regulations and PMA/510(k) medical device development
Excellent understanding of external standards, design controls, quality controls, manufacturing methods
Proven track record of generating and documenting intellectual property
Experience with International Usability Standards and the practical application of Usability Engineering
Experience in defining and execute verification or manufacturing tests
Experience in Industrial Design
Solid understanding of:
Cardiac anatomy, physiology, and biophysics
In-vitro and in-vivo lab activities
ESSENTIAL JOB FUNCTIONS:
This position is in an office / lab environment including working at a desk / on a computer for extended times
Position will involve working in a lab environment with tissue
Position will involve walking, sitting, standing, bending, pushing and pulling on a regular basis, and will involve lifting items up to 25 pounds on a regular basis, and up to 50 pounds on an occasional basis
10% travel possibility
Position contingent upon candidate passing pre-employment physical/drug screen
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.
