Software Quality Engineer I

Medtronic

. Support software quality efforts for Cardiac Ablation Solutions products .

Posted 11/6/2026full-timeUnited StatesMid-LevelSenior💰 $64,800 - $97,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality assurance within regulated environments, particularly in the medical device sector, with a strong focus on compliance with FDA CFR, MDR, IEC 62304, and ISO 13485. Proficient in risk analysis, software coding, and collaboration with cross-functional teams to enhance product reliability and security.

Highest-signal resume keywords

Software Quality AssuranceRisk AnalysisPython ProgrammingMedical Device ComplianceCybersecurity Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software CodingRisk AnalysisDocumentation DevelopmentQuality Metrics TrackingTest Method Recommendation

Soft Skills

Excellent Communication SkillsCollaboration

Tools & Technologies

PythonQtDockerLinux

Industry Keywords

FDA CFRMDRIEC 62304ISO 13485Cardiac Ablation SolutionsElectrophysiology

Tech Stack

Tools & technologies

Cyber SecurityDockerLinuxPythonQt

About the role

Key responsibilities & impact

Support software quality efforts for Cardiac Ablation Solutions products
Ensure compliance with FDA CFR, MDR, IEC 62304, and ISO 13485
Serve as a member of the extended quality team for Affera software releases
Collaborate with quality team members to complete assigned functional work within program deadlines
Participate in software risk analysis activities
Provide software quality support for post-market activities, including defect assessments, issue assessments, health risk assessments, and CAPAs
Review and approve Design History File documents related to software and security
Develop and review documentation for traceability, testability, and compliance
Develop expertise in assigned products and projects through engineering lab work and product training
Track software quality metrics and support continuous monitoring and improvement
Recommend design or test methods to improve product reliability and security
Contribute to quality engineering program strategies
Review and support product security testing strategies
Attend a live EP case at least once per year when available and participate in virtual live case learning opportunities
Collaborate with R&D, medical safety, regulatory affairs, and clinical teams
Travel less than 10%

Requirements

What you’ll need

Bachelor's degree and a minimum of 0 years of relevant experience
Proven ability to write new software code
Ability to quickly and effectively read, interpret, and understand existing software code
Must be authorized to work in the country of employment without sponsorship
For baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Excellent written and oral communication skills
Medical device or other regulated industry experience and/or experience working with a software development team
Experience performing formal risk analysis
Experience using or working with Python, Qt, Docker, and Linux
Knowledge of cybersecurity and the software lifecycle within regulated environments
Experience with cardiac/electrophysiology medical specialties

Benefits

Comp & perks

Competitive salary and flexible benefits package
Short-term incentive through the Medtronic Incentive Plan (MIP)
Health insurance
Dental insurance
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
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums
Temporary employees eligible for paid sick time as required by applicable state law and the Employee Stock Purchase Plan