Principal 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

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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  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.

This position will be part of one or more product development teams where they will responsible for contributing to the on-time development of high-quality products and optimization of core design control business processes.

• 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
• Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
• Provide coaching respective to investigative methods, risk mitigation techniques, Reliability analysis, design control, testing strategies and measurement system analysis (including Six Sigma, FTA, FMEA, 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
• Provide mentorship to junior level design assurance engineers in design control and product development
• Ensure commitment to functional excellence and the ability to execute positive changes

• Regular and predictable work performance
• 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

• Bachelor s degree in Engineering from an accredited college or university or demonstrated equivalent combination of education, training and experience
• Minimum of 7 years of experience in an engineering role in the medical device industry
• Experience in development of and linking product requirements from VOC through to design output and production controls
• Experience with business process development
• Experience in Reliability definition, testing and assessment
• High level of knowledge/experience in statistical analysis techniques
• High level of knowledge/experience in test method strategies,…