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.

Duties include:

• 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; and
• 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.

Required:

• 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. Also requires:
• 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.

Experience may be gained concurrently. Ability to pass pre-employment drug screen and background check is required.

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