Software Quality Engineer I

Medtronic

. Support software quality efforts for Cardiac Ablation Solutions products, ensuring compliance with FDA CFR, MDR, IEC 62304, and ISO 13485 .

Posted 11/5/2026full-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, focusing on compliance with FDA CFR, MDR, and ISO standards. Proficient in risk analysis, documentation, and collaboration with cross-functional teams to ensure product reliability and security.

Highest-signal resume keywords

Software Quality AssuranceRisk AnalysisPython ProgrammingMedical Device ComplianceElectrophysiology Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Code WritingSoftware Code InterpretationRisk AnalysisDocumentation DevelopmentQuality Metrics Tracking

Soft Skills

Excellent Communication Skills

Tools & Technologies

QtDockerLinux

Industry Keywords

FDA CFR ComplianceMDR ComplianceIEC 62304ISO 13485Cardiac Ablation Solutions

Tech Stack

Tools & technologies

Cyber SecurityDockerLinuxPythonQt

About the role

Key responsibilities & impact

Support software quality 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 electrophysiology procedures
Collaborate with quality team members to complete assigned functional work within program deadlines
Participate in software risk analysis activities and ensure comprehensive risk file coverage
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, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling
Ensure documentation meets reliability standards and follows QMS processes
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 of quality outcomes
Recommend design or test methods to achieve appropriate product reliability and security
Propose design or testing changes to improve software or process reliability
Contribute to quality engineering program strategies for Medtronic, customer, and regulatory reliability objectives
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 on quality and compliance requirements

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
Excellent written and oral communication skills
Medical device or other regulated industry experience and/or industry 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, including design, development, and post-market support
Experience with cardiac/electrophysiology medical specialties
Advanced degree in a relevant field
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Must be authorized to work in the country of employment without sponsorship
Roles below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment
Travel requirement: <10%

Benefits

Comp & perks

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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Temporary employees are eligible for paid sick time, as required under applicable state law
Employee Stock Purchase Plan for temporary employees