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.

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.

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. May include coaching and training respective to investigative methods, risk mitigation techniques and general safety (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.

Ensure commitment to functional excellence and the ability to execute positive changes.

Bachelor's degree in Engineering from an accredited college or university or demonstrated equivalent combination of education, training and experience. Minimum of 3 years of experience in an engineering role in the medical device industry. Experience with quality system process development. Working knowledge in statistical analysis techniques including Reliability assessment. Experience in test method strategies, development and validation including GR&R. Experience with risk management methodology.

Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485. Ability to create and manage key internal and external partnerships. Excellent written and verbal communication skills. High level of attention to detail. Familiar with product safety and standards. Ability to demonstrate proficiency in issue resolution. Ability to travel 10%.

5 years or more experience in an engineering role in Medical Devices. 3 or more years' experience working with Product…