Design Assurance Quality Engineer

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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Design Assurance Quality Engineer

AtriCure, Inc. has an opening for the Design Assurance Quality Engineer position in Mason, OH. This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development of high-quality products and optimization of core design control business processes. Anticipated less than 10% domestic travel to AtriCure sites and customer sites with work from home flexibility 40% of time.

Duties include:

• On time quality delivery of assigned product development team deliverables.
• Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations.
• Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities.
• Drive continuous improvements through observation, measurement and root cause analysis/resolution.
• Develop new processes which support speed, cost reductions and quality improvements.
• Provide subject matter expertise for assigned processes to users, as necessary.
• Cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions.
• May include coaching and training respective to investigative methods, risk mitigation techniques and general safety (including Six Sigma, FTA, FEMA, HALT, etc.).
• Provide guidance for development of manufacturing test/evaluation methods and process validation.
• Provides investigative support/leadership for product quality issues.
• Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls.
• Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.
• Serve as technical resource for problem investigations to guide root cause analysis and corrective action development.

Required:

• Bachelor’s in Mechanical Engineering, Industrial Engineering, or closely related field (foreign equiv. accepted) & 3 years of experience as an Engineer or closely related in the medical device industry OR Master’s degree in Mechanical Engineering, Industrial Engineering, or closely related field (foreign equiv. accepted) & 2 years of as an Engineer or closely related in the medical device industry.
• 3 years (2 w/ Masters) experience in both of the following:
  • Risk management methodology; and
  • Processes related to Design Change Control, Design Reviews and Requirements Management.
• 2 years of experience in each of the following:
  • With Medical Device Quality Management Systems (FDA QSR 21 CFR Part 820 and ISO 13485), as well as design, and/or manufacturing of medical devices marketed in the U.S.;
  • Root Cause Analysis methods and Corrective Action development;
  • Supporting and leading FMEAs or essential requirements analysis including standards review and evidence of conformity;
  • Working with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls;
  • Leading cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions; and
  • Data analysis of complaints (such as Adverse Events, or Reportable Events) to remediate the risk management files.
• 1 years of experience in each of the following:
  • Support to development of Hazard Analysis (subset of Risk Management);
  • Developing manufacturing test/evaluation methods, GR&R, or process validation; and
  • Driving continuous improvements through observation, measurement, and root cause analysis/resolution.
• Ability to pass pre-employment drug screen and background check is required.

Experience may be gained concurrently.

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