Software Quality Engineer II at Medtronic driving quality for cardiac electrophysiology systems. Collaborating with engineering teams to ensure compliance with regulatory standards and improve patient outcomes.
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 a member of the extended quality team for operating system 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
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 and process 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 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 business needs permit, periodically visit manufacturing and servicing facilities to aid in understanding of quality processes related to software loading and tooling
Regularly participate in virtual electrophysiology patient case learning opportunities
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements
Requirements
Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years of relevant experience
Ability to demonstrate basic competency in coding, and effectively read, interpret, and understand existing software code
Excellent written and oral communication skills
1+ years of 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
Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar)
Benefits
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
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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