R&D Engineer - Product Development, MedTech

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® Synergy™ 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 AF™ 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 AtriCure.com or follow us on Twitter @AtriCure.

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• About The Role

This position will contribute to the research and development of next-generation medical technologies within AtriCure's product development organization. The engineer will work within a cross-functional team environment and be expected to own designated workstreams from concept through testing and documentation.

Responsibilities may include serving as a usability lead, designing and executing laboratory testing, developing prototypes, performing data analysis, supporting design verification activities, and contributing to regulatory submissions. The individual will collaborate closely with mechanical, electrical, software, and clinical stakeholders to advance innovative technologies toward commercialization.

Essential Function of the Position

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.

Collaborate with electrical, embedded software, and systems engineering teams during product development activities.

Support integration and testing of hardware, software, and system-level solutions.

Support preparation of documentation, testing, and technical evidence required for regulatory submissions.

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 clinical 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.

Plan and execute design verification testing activities.

Build, evaluate, and troubleshoot prototype and test systems.

Analyze experimental and performance data to support product development decisions.

Support cryo laboratory testing and product evaluation activities.

Prepare technical documentation supporting product development and design control activities.

Participate in usability engineering activities and design validation efforts.

Support FDA submission activities and regulatory documentation as required.

Additional Functions of the Role

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

Basic Qualifications

Bachelor’s degree required in Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training and experience

1-5 years of experience in engineering, product development, biomedical engineering, medical devices, or a related technical discipline.

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

FDA design controls, product development processes, and regulated medical device environments preferred.

A track record of:

Creative problem solving

Prioritizing tasks and producing deliverables per schedule expectations

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

Experience supporting animal studies, preclinical research, or procedural development activities is helpful but not required.

Ability to read technical specifications, blueprints, and drawings

Ability to travel 10%

Preferred Qualifications

BS in Biomedical Engineering

MS in Engineering or Life Sciences discipline

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

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

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• 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, 30 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:

https://www.atricure.com/careers-atricure/benefits

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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-verify.gov 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).

You may access our global privacy policy here

https://www.atricure.com/privacy