Mechanical Engineer

Location: Minneapolis, MN
Department: Research & Development
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2019-130
Office based or Remote: Office Based

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

POSITION SUMMARY:

The Mechanical Engineer contributes to the development of ablation products that treat atrial fibrillation. Job performance requires application of technical abilities, knowledge of mechanical engineering, and an understanding of product development methodologies.  Deliverable outputs include analysis, design, evaluation, 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:

  • Design, develop, analyze, and test medical/surgical components, equipment, and instruments
  • Develop product performance requirements as well as assembly and component specifications
  • Perform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomes
  • Serve as a technical resource for materials science applications in product development
  • Conduct laboratory activities related to new product development, including in-vitro and in-vivo studies
  • 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

 

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance
  • 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 or demonstrated equivalent combination of education, training and experience.
  • 3 years of experience in mechanical engineering or similar field including catheter-based technologies (design and manufacture)
  • Understanding of development life cycle including needs assessment, 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
  • A track record of:
    • Creative problem solving
    • Evaluating user needs and generating solutions
    • Prioritizing tasks and producing deliverables per schedule expectations
    • Completion of significant and broad tasks with limited direct supervision
    • Demonstrated proficiencies of communicating best practices
  • Experience and success working in a team environment
  • Excellent written and oral communication skills
  • Experience with data analysis, problem-solving, troubleshooting, and formal root cause analysis
  • Experience in test method development and validation
  • Experience in execution of verification tests and generating test reports
  • Ability to read and create technical specifications, blueprints, and drawings
  • Familiarity with:
    • Materials Science as it pertains to medical device development
    • Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
    • External Standards, Design controls, Quality controls, Manufacturing methods
    • Statistical methods
  • Ability to travel 10%

 

PREFERRED QUALIFICATIONS:

  • MS in Mechanical Engineering or Materials Science
  • 5 years of experience in mechanical engineering or similar field
  • Experience in mechanical engineering for medical device product development
  • Expertise in Materials Science for medical device development
  • Excellent demonstrated ability with statistics-based data analysis, problem-solving, and troubleshooting
  • Track record of managing technical development tasks exhibiting comprehensive planning and thorough communication
  • Excellent understanding of medical device industry regulations and PMA/510(k) medical device development
  • Excellent understanding of external standards, design controls, quality controls, manufacturing methods
  • Proven track record of generating and documenting intellectual property
  • Experience with International Usability Standards and the practical application of Usability Engineering
  • Experience in defining and execute verification or manufacturing tests
  • Experience in Industrial Design
  • Solid understanding of:
    • Cardiac anatomy, physiology, and biophysics
    • In-vitro and in-vivo lab activities

 

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
  • Ability to pass pre-employment drug screen and background check

 

AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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).

 

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 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, 15 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/benefits




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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