Software Quality Engineer I

About the Role

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. This role supports software quality efforts for Cardiac Ablation Solutions products and serves as a member of the extended quality team for Affera software releases used for electrophysiology procedures. The position requires a minimum of 4 days a week onsite.

Key Responsibilities

• Support software quality efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
• Serve as a member of the extended quality team for Affera software releases used for electrophysiology procedures.
• Collaborate with other quality team members to complete 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, including defect assessments, issue assessments, health risk assessments, and CAPAs.
• Review and approve 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.
• 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.
• 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.

Requirements & Tech Stack

• Proven ability to write new software code.
• Quickly and effectively read, interpret, and understand existing software code, to collaborate and execute necessary work with software engineers.
• This is not a coding role.

Qualifications

• Bachelor's degree.
• Minimum of 0 years of relevant experience.
• Applicants must be authorized to work in the country of employment without sponsorship.

Preferred Qualifications

• Excellent written and oral communication skills.
• Medical device or other regulated industry (such as defense or aerospace) experience and/or industry experience working with a software development team.
• Experience performing formal risk analysis.
• Experience using or working with Python, Qt, Docker, and Linux.
• Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
• Experience with cardiac/electrophysiology medical specialties.
• Advanced degree in a relevant field.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.