Software Quality Engineer II
Medtronic
AWSCyber SecurityDartDockerFlutterLinuxPythonReact
Software Quality Engineer II
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Cleveland • Ohio • 🇺🇸 United States
Visit company websiteSalary
💰 $80,800 - $121,200 per year
Job Level
JuniorMid-Level
Tech Stack
AWSCyber SecurityDartDockerFlutterLinuxPythonReact
About the role
- Support software quality and reliability efforts for Cardiac Ablation Solutions products
- Ensure 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
- Ensure all documentation meets reliability standards and follows QMS processes
- Develop and review documentation for traceability, testability, and compliance
- Develop expertise in assigned products and projects
- Participate in software and process risk analysis and defect assessments
- Contribute to tracking software quality metrics for assigned programs
- Provide software quality support for post-market activities and analysis
- 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
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams
Requirements
- 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
- Ability to demonstrate basic competency in coding and effectively read, interpret, and understand existing software code
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
codingrisk analysisFMEAsFTAssoftware quality metricstraceabilitytestabilitycompliance
Soft skills
collaborationaccountability
Certifications
Bachelor's degreeMaster's degreeSix SigmaASQ
