Senior Research and Development Engineer

AtriCure • Mason, OH

20h

About The Position

This position will contribute to the research and development of the next generation of AtriCure products including RF, Cryo and LAA management and potential adjacent therapies and technologies new to AtriCure. Beyond displaying knowledge of core engineering and scientific principles, this position requires excellent teamwork, communication, curiosity, and organizational skills to assist us in growing our business. The person in this position will work within a project team environment to develop novel and/or next generation medical devices used by cardiologists, electrophysiologists, and cardiac surgeons. Responsibilities will include design planning, prototype design and build, design analysis, design documentation, test method development, risk management, design verification and validation leadership, usability validation, design transfer to manufacturing, as well as interaction with surgeons and VOC gathering. Most work will be performed in the context of multi-disciplinary teams and under the direction of the engineering manager or a project manager. In addition to the above requirements, experience and knowledge of life/medical sciences, healthcare practices and procedures is preferred.

Requirements

• Bachelor’s degree required in Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training, and experience
• 5+ years of experience in similar role.
• Solid understanding of: Anatomy, physiology, and biophysics
• Solid understanding of: In-vitro and in-vivo lab activities
• Solid understanding of: Medical device design and prototyping
• Solid understanding of: External Standards, Design controls, Quality controls, Manufacturing methods
• Solid understanding of: Clinical procedure development
• Solid understanding of: Language of medicine
• Familiarity with: Design Controls and FDA QSR 21 CFR Part 820
• Familiarity with: ISO 13485 and ISO14971
• A track record of: Creative and structured problem solving
• A track record of: Prioritizing tasks and producing deliverables per schedule expectations
• A track record of: Conducting and reporting laboratory and animal research studies
• A track record of: Completion of significant technical and broad tasks with limited direct supervision
• Demonstrated proficiencies of communicating engineering best practices
• Understanding of development life cycle including needs assessment, drafting product requirements, 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
• Excellent written and oral communication skills
• Experience and success working in team environment
• Experience with data analysis, problem-solving, and troubleshooting
• Experience with International Usability Standards and the practical application of Usability Engineering
• Ability to read technical specifications, blueprints, and drawings
• Ability to travel 10%

Nice To Haves

• BS in Biomedical or Mechanical Engineering
• MS in Mechanical Engineering or Life Sciences discipline
• Strong knowledge in DFM of molded, machined, and thermoformed components
• Experience with plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding
• Practical working experience with Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack analysis
• Advanced in SolidWorks 3D modeling, standard analysis tools and methodologies
• Excellent demonstrated ability with data analysis, problem-solving, and troubleshooting
• 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

Responsibilities

• Aid in the design and development of novel RF/Cryo ablation devices and LAA management devices including ownership of assigned subsystems or components
• Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
• Collect, organize, and interpret design inputs including voice of customer (VOC) and voice of business
• Participate in the development of product specifications and requirements documents, ensuring traceability and alignment with user needs
• Design and build prototypes using various rapid prototyping methods to test design concepts
• Create and review 3D CAD part files, assemblies, and associated drawings including interpretation of GD&T and tolerance analysis.
• Interface with suppliers to develop processes, optimize component design, and support manufacturability
• Perform structural, fatigue, and thermal analysis for complex medical device components, subassemblies, assemblies, and systems.
• Ability to perform geometric tolerancing analysis and provide design recommendations
• Provide design feasibility recommendations based on material selection , processes, and functional requirements
• Use scientific and engineering principles to test device performance. Record, analyze, and interpret data using appropriate statistical tools. Develop conclusions and clearly communicate findings
• Troubleshoot new designs and/or develop reliability improvements for existing designs
• Develop and validate test methods, including fixtures and protocols, for characterization, verification, and validation activities
• Provide testing, analysis, and reporting to predict and verify the human body interactions with designed devices
• Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design related risks are identified and appropriately mitigated
• Conduct clinical laboratory activities related to new product development, including animal research studies and procedure development
• Be knowledgeable of surgical techniques, devices and procedures and be comfortable using them in a preclinical lab setting.
• Work with Key Opinion leaders to collect Voice of Customer data and develop and identify product requirements.
• Generate and document intellectual property
• 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

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• On-site fitness center (Corporate-based employees)
• Cafeteria (Corporate-based employees)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees