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 work closely with Atri Cure 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 experience
• Computer/data entry skills
• Written/report writing skills
• Experience training production associates, inspectors, or junior engineers.
• Experience with industrial or manufacturing statistics

PREFERRED QUALIFICATIONS:

• MDD, MDR, CMDR and JPAL knowledge
• Regulatory experience
• Experience with design verification / design validation
• Knowledge of EO and Gamma sterilization processes.
• Eng…