Software Quality Engineer II

Medtronic • Newton, MA

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 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 operating systems and manufacturing/service tooling software releases 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.

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

Nice To Haves

• 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).

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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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).
• 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees