Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients.
Atri Cure's cryo ICE cryo SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit or follow us on potential applicants are encouraged to scroll through and read the complete job description before applying.
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 contribute to the research and development of the next generation of Atri Cure products including RF, Cryo and LAA management and potential adjacent therapies and technologies new to Atri Cure. 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, usability validation, 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 a senior engineer or project manager. In addition to the above requirements, experience and knowledge of life/medical sciences, healthcare practices and procedures is preferred.
ESSENTIAL FUNCTIONS OF THE POSITION: Aid in the design and development of novel RF/Cryo ablation devices and LAA management devices Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes Collection, organization, and analysis of design inputs including voice of customer and voice of business Participate in the development of product specifications and requirements documents Design and build prototypes using various rapid prototyping methods to test design concepts Ability to review and provide 3D CAD part files, assemblies, and associated drawings Interface with suppliers to develop processes and optimize designs of components and sub-assemblies Perform structural, fatigue, and thermal analysis for complex medical device component, subassemblies, assemblies, and systems.
Ability to perform geometric tolerancing analysis and provide design recommendations Provide recommendations regarding design feasibility given specified materials, processes, and designs Use scientific principles to test performance of medical devices.
Record data using appropriate tools and analyze with statistical rigor. Develop conclusions, and present recommendations in written and verbal communications Troubleshoot new designs and/or develop reliability improvements for existing designs Develop and validate test methods Provide analysis, testing, and reporting to predict and verify the human body response to 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 ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: 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 BASIC QUALIFICATIONS: Bachelor's degree required in Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training, and experience Solid understanding of: Anatomy, physiology, and biophysics In-vitro and in-vivo lab activities Medical device design and prototyping External Standards, Design controls, Quality controls, Manufacturing methods Clinical procedure development Language of medicine Familiarity with: Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485A track record of: Creative problem solving Prioritizing tasks and producing deliverables per schedule expectations Conducting and reporting laboratory and animal research studies Completion of significant and broad tasks with limited direct supervision Demonstrated proficiencies of communicating best practices Understanding of development life cycle including needs backssment, 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 requirementinteractioncellent written and oral communication skillinteractionperience 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%PREFERRED QUALIFICATIONS: BS in Mechanical Engineering MS in Mechanical Engineering or Life Sciences discipline Strong knowledge in DFM of molded, machined, and thermoformed componentinteractionperience 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 Solid Works 3D modeling, standard analysis tools and methodologieinteractioncellent 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 deviceinteractioncellent understanding of external standards, design controls, quality controls, manufacturing methods Proven track record of generating and documenting intellectual property OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check#LI-RD1Atri Cure 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: /benefits Atri Cure 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 www.
e-verify. gov/ Atri Cure 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, interaction, national or ethnic origin, age, protected veteran status, status as an individual with disability, interactionual orientation, gender identity or any other characteristic protected by federal, state, or local law(s). PDN-9ab99dae-c386-405f-8183-f19c5e2c4fdd For more details: jobs-search. org/manufacturing_mason-c443401/senior-rd-engineer-mason_i1959025614
