Product Quality Engineer

Atricure, Inc. - Cincinnati, OH

Posted: 5/5/2024 - Expires: 8/3/2024

Job ID: 273165428

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Job Description

Quality Engineer

Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA
Req #2059

Monday, April 29, 2024

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 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.
Engineering/design background

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

#LI-RS1

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ 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 disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

Job Family
Quality Engineering

Job Function
Quality

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

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Job Summary

Employment Type:: Full Time Employee
Job type:: Federal Contractor
Skill Based Partner:: No
Education Level:: Bachelor's degree
Work Days:: Mon, Tue, Wed, Thu, Fri
Job Reference Code: 79274695
Salary: N/A
Licenses / Certifications:: N/A; Applied Math: 6; Graphic Literacy: 6; Workplace Documentation: 5

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Product Quality Engineer

Atricure, Inc. - Cincinnati, OH

Job Description

Job Summary