AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
This position will This is a technical position assuming various years of experience and different job roles. An Engineering degree or equivalent is required. The job performance requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems. The Senior Quality Engineer, Operations works closely with AtriCure engineering, manufacturing, supplier quality, and suppliers to ensure that quality system activities are completed. This individual will have a strong technical foundation and must be able to lead and coordinate activities related to daily operations. This individual will operate regularly with a cross functional team and shall contribute to the creation of a collaborative work environment.
ESSENTIAL FUNCTIONS OF THE POSITION:
Provides Quality Engineering support for products generally acquired as finished devices (less some value-added operations).The products within this category will require routine collaboration with key suppliers and internal functions.Daily tasks require the timely addressing of product line issues through correction and prevention processes.
With respect to direct product responsibility, the Acquired Products QE manages, and coordinates required activities from external (supplier) and internal functions (ie. Engineering, Manufacturing, Quality, Inspection, Document Control) and processes (ie. Product qualification, process validation, NCRs, FMEA’s, Rework, Deviations)
Chairs the MRB for respective product line.
Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with minimal 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
Assists in the further development of quality engineers.
Performs other duties as assigned
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable worksite attendance
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
Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
5+ years of experience
Knowledge/experience working with contract suppliers of finished devices.
Knowledge/experience with sterile packaging of disposable medical devices.
Knowledge/experience with EO and Gamma sterilization validation and continuous monitoring.
Proficient in interpreting design drawings (including GD&T) and product specifications
Test Method Validation/Gage R&R experience
Problem Solving/Troubleshooting experience
Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc.
Strong interpersonal, organizational, and communication skills.
Verbal communication and people skills
FDA and ISO 13485 knowledge
Data analysis experience
Computer/data entry skills
Written/report writing skills
Experience with industrial or manufacturing statistics
Ability to travel 25%
MDD, CMDR and JPAL knowledge
ASQ Certified Quality Engineer and/or Auditor
Experience training production associates, inspectors, and training/mentoring junior engineers.