Design Assurance Quality Engineer

Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

Atri Cure, Inc. has an opening for the Staff Design Assurance Quality Engineer in Mason, Ohio responsible for contributing to the on‑time development of high‑quality products, supporting and leading activities related to trending quality field performance, and subsequent improvement for marketed products and optimization of design control processes. 60% on site at headquarters, 40% remote work allowed.

• On time quality delivery of assigned product development team deliverables; ensuring assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations
• Optimizing existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities
• Driving continuous improvements through observation, measurement, and root cause analysis/resolution
• Developing new processes which support speed, cost reductions, and quality improvements
• Providing subject matter expertise for assigned processes to users as necessary
• Cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
• Providing coaching regarding investigative methods, risk mitigation techniques, DOE, statistical analysis, reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
• Providing guidance for development of manufacturing test/evaluation methods and process validation
• Providing investigative support/leadership for product quality issues
• Working with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
• Working 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
• Serving as technical resource for problem investigations to guide root cause analysis and corrective action development
• Providing mentorship to junior level design assurance engineers in design control and product development
• Ensuring commitment to functional excellence and the ability to execute positive changes
• Up to 10% domestic travel to other company sites to participate in cases/labs

• Bachelor's degree in Engineering discipline or related (foreign equivalent degree accepted) with 7 years of progressive, post degree experience as an engineer or related role OR Master's in Engineering discipline or related (foreign equivalent degree accepted) with 5 years of experience as an engineer or related role
• 5 years of experience in each of the following:
  • Risk management methodology in compliance with ISO‑14971 including Preliminary Hazard Assessment, Application FMEA, Software FMEA, Design FMEA, Risk Planning, and Risk Reporting
  • Change Control of commercialized medical device products in compliance with FDA QSR (21 CFR Part 820),…