Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of software for Affera cardiac electrophysiology systems.  By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide. 

Primary Responsibilities 

• Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. 

• Serve as member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures.  Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines. 

• Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all documentation meets reliability standards and follows QMS processes. 

• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures. 

• Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned. 

• Participate in software risk analysis and defect assessments as assigned. 

• Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability. 

• Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.  

• Recommend design or test methods to achieve appropriate levels of product reliability and security. Propose changes to design or testing as necessary to improve software and/or process reliability.   

• Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.