Staff Design Assurance Quality Engineer

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. 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. POSITION SUMMARY: 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 AtriCure’s QMS planning, execution and implementation activities for New Product Development.

Requirements

, generation of risk management report/benefit analyses, and participation in post-market product surveillance. ESSENTIAL FUNCTIONS OF THE POSITION: 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.

, design specifications, design verification and validation strategies, usability studies, process

through manufacturing

, 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. ) 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.

Qualifications

, design reviews and transfer.