Sr. Software Quality Engineer at Medtronic Newton, MA

Medtronic; Newton (MA); On-site; USD 102,400 - 153,600; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) plan with employer contribution

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Job summary

Medtronic is seeking a Senior Software Quality Engineer in Newton, MA. You will partner with engineering and clinical teams to ensure software meets high standards of quality and regulatory compliance. Responsibilities include reviewing design documents, ensuring product reliability, and tracking quality metrics.

The ideal candidate should have a Bachelor's degree with 4+ years of relevant experience, and familiarity with regulated industries. Strong communication skills and experience with software development are preferred.

Qualifications

• Bachelor’s degree and a minimum of 4 years of relevant experience.
• Master’s degree with a minimum of 2 years of relevant experience.
• PhD with 0 years of relevant experience.
• At least 1 year of experience supporting product development.
• 2+ years of experience in medical device or regulated industry.

Responsibilities

• Support software quality and reliability efforts for cardiac ablation products.
• Review and approve Design History File documents related to software.
• Track software quality metrics for continuous improvement.
• Provide quality support for post-market activities.

Skills

Experience supporting product development

Excellent written and oral communication skills

Understanding of existing software code

Knowledge of cybersecurity

Familiarity with software lifecycle in regulated environments

Education

Bachelor’s degree

Master’s degree

PhD

Tools

Python

Qt

Docker

Linux

Job description

Senior Software Quality Engineer

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

Overview

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.

Primary Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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).

Travel Requirement

<10% of the time.

Physical Job Requirements

Office role requiring independent mobility, regular computer use, and interaction with peers and coworkers. Reasonable accommodations are available for individuals with disabilities.

Benefits & Compensation

Salary range (U.S.): $102,400.00 – $153,600.00 (USD). Eligible for Medtronic Incentive Plan (MIP). Compensation information may vary based on experience, certification, and location.

• 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).
• 401(k) plan with employer contribution and match.
• Short‑term and long‑term disability.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non‑qualified retirement plan supplement.
• Capital Accumulation Plan for eligible executives.

Equal Employment Opportunity

Medtronic provides equal employment opportunity to all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, genetic information, marital status, public assistance status, veteran status, and other characteristics protected by law. Reasonable accommodations are available for qualified individuals with disabilities.