Medtronic is hiring a Software Quality Engineer I to support quality for the design, development, release, and maintenance of software for Affera cardiac electrophysiology systems. The role supports regulatory compliance, software risk and post-market activities, quality documentation, and collaboration with cross-functional teams to improve product reliability and security.
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 member of the extended quality team for Affera software releases used for electrophysiology procedures. 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
Qualification
Required
Applicants must be authorized to work in the country of employment without sponsorship
Bachelor's degree and a minimum of 0 years of relevant experience
Though this is not a coding role, the candidate must have 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
Preferred
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
Benefits
Short-term incentive called the Medtronic Incentive Plan (MIP)
For regular employees who work 20+ hours per week: Health, Dental and vision insurance
For regular employees who work 20+ hours per week: Health Savings Account
For regular employees who work 20+ hours per week: Healthcare Flexible Spending Account
For regular employees who work 20+ hours per week: Life insurance
For regular employees who work 20+ hours per week: Long-term disability leave
For regular employees who work 20+ hours per week: Dependent daycare spending account
For regular employees who work 20+ hours per week: Tuition assistance/reimbursement
For regular employees who work 20+ hours per week: Simple Steps (global well-being program)
For all regular employees: Incentive plans
For all regular employees: 401(k) plan plus employer contribution and match
For all regular employees: Short-term disability
For all regular employees: Paid time off
For all regular employees: Paid holidays
For all regular employees: Employee Stock Purchase Plan
For all regular employees: Employee Assistance Program
For all regular employees: Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
For all regular employees: Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
For temporary employees: paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
