Associate 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.

POSITION SUMMARY:

This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development and sustaining of high-quality products and optimization of core design control business processes. ESSENTIAL FUNCTIONS OF THE POSITION:
On time quality delivery of assigned product development team deliverables, under the guidance of a more senior Design Assurance team member 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 Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions Provide guidance for development of manufacturing test/evaluation methods and process validation Provides investigative support for product quality issues Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls, and with sustaining teams to assure proposed changes still meet those requirements Work with product development teams on timely use of Risk Management activities including supporting 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 ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
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

BASIC QUALIFICATIONS:

Bachelor's degree in Engineering from an accredited college or university or demonstrated equivalent combination of education, training and experience 1-3 years of professional experience in a regulated manufacturing industry. Co-op and internship experience is considered relevant experience for this role.

Experience with quality system process development Working knowledge of statistical analysis techniques Experience in test method strategies used for design verification and validation

Experience with risk management methodology 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%

PREFERRED QUALIFICATIONS:

At least 1 year experience in an engineering role in Medical Devices At least 1 year experience working with Product Development Experience in processes related to Design Change Control, Design Reviews, Requirements Management

Experience with medical device electrical and software standards, testing and marking Working knowledge of Reliability assessment techniques Experience developing test method strategies, including GR&R OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check Ability to regularly lift up to 25 pounds #LI-KN1

Atri Cure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of…