Staff Design Assurance Quality Engineer

AtriCure, Inc.•Mason, OH

39d•Hybrid

About The Position

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. Staff Design Assurance Quality Engineer AtriCure, Inc. has an opening for the Staff Design Assurance Quality Engineer in Mason, Ohio responsible for contributing to the on-time development of high-quality products, supporting and leading activities related to trending quality field performance, and subsequent improvement for marketed products and optimization of design control processes. 60% on site at headquarters, 40% remote work allowed.

Requirements

Bachelor's degree inEngineering discipline or related (foreign equivalent degree accepted) with 7 years of progressive, post degree experience as an engineer or related role OR Master's in Engineering discipline or related (foreign equivalent degree accepted) with 5 years of experience as an engineer or related role.
5 years of experience in each of the following: Risk management methodology in compliance with ISO-14971 including Preliminary Hazard Assessment, Application FMEA, Software FMEA, Design FMEA, Risk Planning, and Risk Reporting; Change Control of commercialized medical device products in compliance with FDA QSR (21 CFR Part 820), ISO-13485, IEC-62366, and EU MDR Regulation (EU) 2017/745; Processes related to Design Control, and Design Reviews for Class II/III Devices (US) or 2b/3 devices (EU) including translating VOC to customer requirements and cascading to System and Sub-System requirements to manufacturing requirements and link to production controls; Applying statistical analysis techniques; Test method strategies, development and validation; Demonstrated ability to create and manage key professional relationships internally with other departments as well as externally to facilitate cross-functional collaboration; Demonstrated ability to organize and distill complex information and communicate to a broad audience effectively; and Serving as technical resource, providing investigative support and leadership for product quality issue resolution, including problem investigations to guide root cause analysis and corrective action development.
2 years of experience in each of the following: Compliance with general requirements for basic safety and essential performance standards, such as IEC 60601, IEC-62304; Evaluating processes used for medical device product development and sustaining to make process improvements; Identifying, planning, and executing continuous improvement activities; Providing subject matter expertise for assigned processes to users as necessary; Investigative methods, risk mitigation techniques, Design of Experiments (DOE), Reliability, and other related techniques such as Six Sigma, Highly Accelerated Life Test (HALT), etc.; Mentoring junior level design assurance engineers in design control and product development; and Project Management of a cross-functional team.
Ability to pass pre-employment drug screen and background check is required.

Responsibilities

On time quality delivery of assigned product development team deliverables
Ensuring assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations
Optimizing existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities
Driving continuous improvements through observation, measurement, and root cause analysis/resolution
Developing new processes which support speed, cost reductions, and quality improvements
Providing subject matter expertise for assigned processes to users as necessary
Cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
Providing coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
Providing guidance for development of manufacturing test/evaluation methods and process validation
Providing investigative support/leadership for product quality issues
Working with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
Working 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
Serving as technical resource for problem investigations to guide root cause analysis and corrective action development
Providing mentorship to junior level design assurance engineers in design control and product development
Ensuring commitment to functional excellence and the ability to execute positive changes
Up to 10% domestic travel to other company sites to participate in cases/labs.

Benefits

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/careers-atricure/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).

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