R&D Engineer - Product Development, Medtech

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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