Software Quality Engineer II

Medtronic•Mounds View, MN

1d•Hybrid

About The Position

Join Medtronic as a Software Quality Engineer II 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. This position is not eligible for immigration sponsorship. Applicants must be authorized to work in the country of employment without sponsorship.

Requirements

Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years relevant experience
Proven ability to write new software code, and quickly and effectively read, interpret, and understand existing software code, to collaborate and execute necessary work with software engineers.
Excellent written and oral communication skills.

Nice To Haves

Medical device or other regulated industry (such as defense or aerospace) experience and/or industry experience working with a software development team.
Experience creating risk analysis documentation such as FMEAs and FTAs.
Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart.
Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
Advanced degree in a relevant field.
Experience with cardiac/electrophysiology medical specialties.
Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).

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 therapy software, operating systems, and service/manufacturing tooling software releases across the Affera portfolio.
Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
Participate in software risk analysis activities to ensure comprehensive risk file coverage for software.
Provide software quality support for post-market activities and analysis as assigned, including work supporting defect assessments, issue assessments, health risk assessments, and CAPAs.
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.
Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
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 quality engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.
Review and support strategies for product security testing as assigned.
As available, attend a live EP case at least once per year to enhance workflow and product knowledge.
Regularly participate in virtual live case learning opportunities.
Collaborate with cross-functional teams, including R&D, medical safety, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.