Sr. Software Quality Engineer (Reliability/Compliance)

About the role

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.

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.
• 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, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.

Qualifications

• Bachelor's degree and a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience
• At least 1 year of experience supporting product development
• Excellent written and oral communication skills
• 2+ years of medical device or other regulated industry (such as defense or aerospace) experience
• Experience creating risk analysis documentation such as FMEAs and FTAs
• Experience using or working with products built on Python, Qt, Docker, and Linux
• Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support
• Experience with cardiac and electrophysiology medical specialties
• Advanced degree in a relevant field
• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar)

Skills

• Technical expertise with a passion for quality, compliance, and improving patient outcomes
• Simple coding tasks and effective reading, interpreting, and understanding existing software code
• Collaboration and execution with software engineers

Benefits

Competitive Salary and flexible Benefits Package including Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).