Senior Research and Development Engineer

AtriCure•Mason, OH

2d•Onsite

About The Position

This position will contribute to the research and development of the next generation of AtriCure products, including RF, Cryo, LAA management, and potential adjacent therapies and technologies new to AtriCure. The role requires knowledge of core engineering and scientific principles, excellent teamwork, communication, curiosity, and organizational skills. The Senior Research and Development Engineer will work within a project team environment to develop novel and/or next-generation medical devices used by cardiologists, electrophysiologists, and cardiac surgeons. Responsibilities encompass 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, and interaction with surgeons for Voice of Customer (VOC) gathering. Most work will be performed in multi-disciplinary teams under the direction of an engineering manager or project manager. Experience and knowledge of life/medical sciences, healthcare practices, and procedures are 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