Design Assurance Quality EngineerMason, OH

Staff Design Assurance Quality Engineer, Mason, OH

Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure'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  or follow us on Twitter @Atri Cure.

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.

This position will apply biomedical engineering principles to execute the design controls for medical devices as a part of one or more new product development projects. Ensure product compliance to 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007/2019, MDD 93/42/EEC and EU MDR 22017/745 and 746. This position collaborates with cross-functional teams including Product Development, Manufacturing Operations, Regulatory, Clinical and Marketing to maintain adherence to Atri Cure's QMS planning, execution and implementation activities for New Product Development.

Lead the development and enforcement of Atri Cure's risk management activities to ensure patient and user safety through identification of risk-driven product requirements, generation of risk management report/benefit analyses, and participation in post-market product surveillance.

• On time quality delivery of assigned product development team deliverables by adherence to internal QMS and design controls procedures in compliance with FDA, GMP, ISO and other applicable standards and regulations.
• Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions.
• Responsible to generate and independently maintain project risk management files for new product development projects. These include risk management plans, hazard analysis, Application or Use FMEAs via failure mode effects analysis, risk mitigations and effectiveness checks, and Risk Management Reports using principles from ISO 14971.
• Drive design assurance into product development through support of user needs/VOCs, product design requirements, design specifications, design verification and validation strategies, usability studies, process qualifications, design reviews and transfer.
• Collaborate with Product development teams to define and cascade user needs/VOC to technical system and subsystem level design requirements through manufacturing requirements, develop rationales, establish traceability to detail designs and Design FMEAs.
• Provide expertise in development and implementation of C/R strategy, statistical support, inspection, sampling plans, test methods during Design Verification and Design Validation planning using a risk-based approach.
• Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.).
• Participates or leads Technical Design Phase Reviews.
• Supports Manufacturing Operations with development of Validation Master Plans, Test Method Validations, Process FMEAs, and Process Validations (IQ, OQ and PQs).
• Maintains product DHFs and DMRs.
• Understanding of global standards and regulations including but not limited to FDA and ISO and Labeling, Packaging, Electrical (IEC 60601), Biocompatibility (ISO 10993) and Sterilization (Gamma, EO or other).
• Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.
• 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.
• Provides investigative support/leadership for product quality issues.
• 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…