Product Quality Engineer

Atricure, Inc. • Mason, OH • 2h ago

AtriCure, 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 AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
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 work closely with AtriCure engineering, manufacturing, supplier quality, and suppliers to ensure that quality system activities are completed. This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations.
ESSENTIAL FUNCTIONS OF THE POSITION:
Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional team. Daily tasks require the timely addressing of product line issues through correction and prevention processes.
With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEA's, Rework, Deviations, CAPA)
Chairs the MRB for respective product line.
Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.
Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer
Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
Assists with 3rd party, internal, and external FDA and ISO audits, as necessary
Performs other duties as assigned
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 required in Engineering or demonstrated equivalent combination of education, training and experience.
2 - 5 years of experience in a process, manufacturing, or quality engineering role.
Able to interpret design drawings (including GD&T) and product specifications
Gage R&R experience a plus
Experience with process validation, design verification/design validation
Problem solving/Troubleshooting experience
Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc. a plus
Strong interpersonal, organizational, and communication skills.
FDA and ISO 13485 knowledge
Metrology, auditing and data analysis experienc

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