Sr. Biomedical Engineer

Location: Minneapolis, MN
Department: Research & Development
Employment Duration: Full Time Regular
FLSA Status: Exempt

Description

 

AtriCure, Inc. is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

Position Summary:

The Senior Biomedical Engineer contributes to the development of ablation products that treat atrial fibrillation. Job performance requires application of technical abilities, command of life/medical sciences, healthcare practices and procedures, and a solid understanding of product development methodologies.  Deliverable outputs include analysis, design, evaluation, production transfer, and documentation of products that meet medical and regulatory guidelines. The Senior Biomedical Engineer will play a technical leadership role in the context of multi-disciplinary teams under the direction of a project manager.

 

Roles and Responsibilities:

  • Design, develop, analyze, and test medical/surgical components, equipment, and instruments

  • Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes

  • Lead clinical laboratory activities related to new product development, including animal research studies and procedure development

  • Provide analysis, testing, and reporting to predict and verify the human body response to designed devices

  • Define and execute improvement in methods and processes of the product development organization

  • Mentor junior staff

  • Generate and document intellectual property

     

    BASIC QUALIFICATIONS:

  • BS in Engineering or Life Sciences discipline

  • 7 years of experience in biomedical engineering or equivalent field

  • Solid understanding of:

    • Anatomy, physiology, and biophysics

    • Leading in-vitro and in-vivo lab activities

    • Medical device design

    • Data analysis with statistical methods

    • External Standards, Design controls, and Quality controls

  • Familiarity with:

    • Design Controls standards FDA QSR 21 CFR Part 820 and ISO 13485

    • Medical device manufacturing methods

    • Cardiac and thoracic surgical procedures and terminology

  • A track record of:

    • Creative problem solving, prototyping, and troubleshooting

    • Prioritizing tasks and producing deliverables per schedule expectations

    • Leading teams to successful outcomes

    • Leading and reporting laboratory and animal research studies

    • Completion of significant and broad tasks with minimal supervision

  • Understanding of development life cycle including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation

  • Proficiency acting in and leading integrated process/product teams, as well as coordinating and communicating customer requirements

  • Experience and dedication to mentoring more junior engineers

  • Excellent written and oral communication skills

  • Experience with International Usability Standards and the practical application of Usability Engineering

  • Ability to read and create technical specifications, blueprints, and drawings

     

    PREFERRED QUALIFICATIONS:

  • BS in Biomedical Engineering

  • MS in Engineering or Life Sciences discipline

  • 10 years of experience in biomedical engineering or equivalent field

  • Experience in Materials Science

  • 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

  • Solid understanding of cardiac and thoracic s urgical procedures and terminology

  • Familiarity with project management methods and tools for planning, executing, and reporting results

  • Experience in collaborating with Marketing and Sales disciplines, including establishing and maintaining customer relationships

 

ESSENTIAL JOB FUNCTIONS:

  • Regularly walk, sit, stand, bend and push/pull

  • Lift up to 25 pounds, occasionally lift up to 50 pounds

  • 10% travel possibility

  • Position contingent upon candidate passing pre-employment physical/drug screen

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.

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