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Associate Design Assurance Quality Engineer

2 months ago

Dayton, Ohio, United States AtriCure Full time
About AtriCure

AtriCure, Inc. is a leading medical technology company that provides innovative solutions for the treatment of atrial fibrillation and related conditions. With a global presence, AtriCure's products are used by electrophysiologists and cardiothoracic surgeons to treat atrial fibrillation and reduce complications.

Job Summary

We are seeking a highly skilled Design Assurance Quality Engineer to join our product development team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices with regulatory requirements.

Key Responsibilities
  • Contribute to the development and sustaining of high-quality products and optimization of core design control business processes.
  • Ensure assigned design control procedures are compliant with FDA, GMP, ISO, and other applicable standards and regulations.
  • Optimize existing processes to maximize efficiencies and identify, plan, and execute continuous improvement activities.
  • Drive continuous improvements through observation, measurement, and root cause analysis/resolution.
  • Develop new processes that support speed, cost reductions, and quality improvements.
  • Collaborate with cross-functional teams, including manufacturing operations, marketing, sales, regulatory, and clinical functions.
  • Provide guidance on the development of manufacturing test/evaluation methods and process validation.
  • Investigate product quality issues and provide technical support for problem investigations.
  • Work with product development teams to ensure requirements are cascaded from VOC through manufacturing requirements and linked to production controls.
  • Support the use of Risk Management activities, including FMEAs and essential requirements analysis.
Requirements
  • 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, including co-op and internship experience.
  • Experience with quality system process development, statistical analysis techniques, and test method strategies.
  • Working knowledge of risk management methodology, product safety, and standards.
  • Excellent written and verbal communication skills, with a high level of attention to detail.
  • Ability to travel up to 10%.
Preferred Qualifications
  • At least 1 year of experience in an engineering role in Medical Devices.
  • Experience working with Product Development, Design Change Control, Design Reviews, and Requirements Management.
  • Working knowledge of Reliability assessment techniques and medical device electrical and software standards.
What We Offer

AtriCure offers a comprehensive benefits package, including medical and dental insurance, 401(k) with match, paid parental leave, volunteer time off, and more. Our corporate-based employees also have access to an on-site fitness center and cafeteria.

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 a disability, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local law(s).