Sr. Software Quality Engineer Newton, MA

Senior Software Quality Engineer

Location:

Newton, MA. Application period closes on 24 Nov 2025.

As a Senior Software Quality Engineer at Medtronic, you will partner with engineering, regulatory affairs, and clinical teams to ensure software for Affera cardiac electrophysiology systems meets the highest standards of quality, safety, and regulatory compliance. Your work will directly support products used in cardiac ablation procedures worldwide.

• Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with FDA CFR, MDR, IEC 62304, and ISO 13485.
• Serve as a member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures; coordinate with team members to complete assigned functional work within program deadlines.
• Review and approve Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling.
• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
• Develop expertise in assigned products and projects; participate in engineering lab work and product training as required.
• Participate in software risk analysis and defect assessments.
• Track software quality metrics and support continuous monitoring and improvement of quality outcomes.
• Provide quality support for post‑market activities, including issue assessments, health risk assessments, and corrective and preventive actions (CAPAs).
• Recommend design or test methods to achieve appropriate levels of product reliability and security; propose changes as necessary to improve software and/or process reliability.
• Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives.
• Review and support strategies for product security testing.
• 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 align on quality and compliance 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 of relevant experience.

• At least 1 year of experience supporting product development.
• Ability to perform simple coding tasks and understand existing software code.
• Excellent written and oral communication skills.
• 2+ years of medical device or other regulated industry experience, such as defense or aerospace.
• 2+ years of experience working with a software development team.
• Experience creating risk analysis documentation such as FMEAs and FTAs.
• Experience with products built on Python, Qt, Docker, and Linux.
• Strong knowledge of cybersecurity and the software lifecycle within regulated environments.
• 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).