Medtronic · 17 hours ago
Software Quality Engineer II
Newton, Massachusetts, United States of America
Full-time
Onsite
Entry, Mid Level
$81K/yr - $121K/yr
2+ years expMedtronic is a leader in global healthcare technology, committed to alleviating pain and restoring health. As a Software Quality Engineer II, you will support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards and contributing to the development and maintenance of software for medical devices.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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
Travel Requirements <15%
Qualification
Required
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
Preferred
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
Medical Device Network
2026-01-16
Mexico Business
2026-01-16
Medical Product Outsourcing
2026-01-16
Company data provided by crunchbase