- Design, develop, analyze, and test medical devices using various test equipment, and instruments.
- Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes.
- Build prototypes using various rapid prototyping methods to test design concepts.
- 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.
- 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.
- Conduct preclinical laboratory activities related to new product development, including animal research studies and procedure development.
- Analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety, and use results to assess and mitigate risk.
- Provide analysis, testing, and reporting to predict and verify the human body response to designed devices.
- Contribute to improvement in methods and processes of the product development organization.
- Generate and document intellectual property.
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgement
- 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 Life Sciences discipline or demonstrated equivalent combination of education, training and experience
- 3 years of experience in biomedical engineering or equivalent field
- Solid understanding of:
- Anatomy, physiology, and biophysics
- In-vitro and in-vivo lab activities
- Medical device design
- Clinical procedure development
- Language of medicine
- Familiarity with:
- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
- External Standards, Design controls, Quality controls, Manufacturing methods
- A 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 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%
- BS in Biomedical Engineering
- MS in Engineering or Life Sciences discipline
- 5 years of experience in biomedical engineering or equivalent field
- 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
- 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
- Job Family Biomedical Engineer
- Job Function Research & Development
- Pay Type Salary
- Employment Indicator Non Manager
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Biomedical Engineer - Cincinnati, United States - AtriCure
Description
AtriCure, Inc. provides innovative technologies for the treatment of 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 SynergyTM Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AFTM Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE 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 Twitter @AtriCure.
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 AtriCure products including RF, cryo and LAA management and potential adjacent therapies and technologies new to AtriCure. Job performance requires application of technical abilities, knowledge of life/medical sciences, healthcare practices and procedures, and an understanding of product development methodologies. Deliverable outputs include design, analysis, bench, in-vitro, and in-vivo testing, 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.
ESSENTIAL FUNCTIONS OF THE POSITION:
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, 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: 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- AtriCure 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, 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).
Other details
