AtriCure, Inc. · 1 day ago
Quality Engineer
Mason, OH
Full-time
Onsite
Entry, Mid Level
2+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Quality Engineer will work closely with engineering, manufacturing, and suppliers to ensure quality system activities are completed, managing and coordinating activities related to daily operations and product line issues.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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
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
Qualification
Required
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
MDD, MDR, CMDR and JPAL knowledge
Regulatory experience
Experience with design verification / design validation
Knowledge of EO and Gamma sterilization processes
Engineering/design background
Benefits
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
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Recent News
Company data provided by crunchbase