AtriCure, Inc. · 10 hours ago
Staff Design Assurance Quality Engineer
Mason, OH
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expAtriCure, Inc. is seeking a Staff Design Assurance Quality Engineer to contribute to product development teams focused on high-quality products. The role involves ensuring compliance with design control procedures, optimizing processes, and providing subject matter expertise while collaborating cross-functionally.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
On time quality delivery of assigned product development team deliverables
Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations
Optimize existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities
Drive continuous improvements through observation, measurement, and root cause analysis/resolution
Develop new processes which support speed, cost reductions and quality improvements
Provide subject matter expertise for assigned processes to users as necessary
Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
Provide guidance for development of manufacturing test/evaluation methods and process validation
Provides investigative support/leadership for product quality issues
Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity
Serve as technical resource for problem investigations to guide root cause analysis and corrective action development
Provide mentorship to junior level design assurance engineers in design control and product development
Ensure commitment to functional excellence and the ability to execute positive changes
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
Ability to mentor and coach others
Additional duties as assigned
Qualification
Required
Bachelor's degree in Engineering required or demonstrated equivalent combination of education, training and experience
Minimum of 7 years of experience in an engineering role in the medical device industry
Experience with business process development
High level of knowledge in statistical analysis techniques
High level of experience in test method strategies, development and validation including GR&R
High level of experience with risk management methodology
Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
Ability to create and manage key internal and external partnerships
Excellent written and verbal communication skills
High level of attention to detail
Familiar with product safety and standards
Ability to demonstrate proficiency in issue resolution
Ability to multi-task and work with little direction
Ability to manage multiple priorities
Familiar with product safety standards
Ability to travel 10%
Preferred
10 years or more experience in an engineering role in Medical Devices
7 or more years' experience working with Product Development
Experience in processes related to Design Change Control, Design Reviews, Requirements Management
Certification in ASQ, Six Sigma/Design for Six Sigma
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
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
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