Sr. Software Quality Engineer

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 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 . 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 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
• <10% Travel Requirement

Nice To Haves

• Bachelor’s degree in software engineering, computer engineering, electrical engineering, biomedical engineering, or a related technical field.
• Minimum of 4 years of experience across any of the following disciplines: software development or testing, quality or reliability engineering, or field/research experience in a cardiac electrophysiology lab, or 2 years of experience with advanced degree.
• At least 1 year of experience supporting product development.
• Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code.
• Excellent written and oral communication skills.
• 2+ years of medical device or other regulated industry (such as defense or aerospace) experience.
• 2+ 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, 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).

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.
• Participate in software risk analysis and defect assessments as assigned.
• Provide software quality support for post-market activities and analysis, including work supporting 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 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level