✦ Luna Orbit — QA & Testing

Software Design Quality Engineer II

at Johnson & Johnson

📍 Danvers, Massachusetts, United States of America Hybrid 💰 $92K – $148K USD / year Posted March 26, 2026
Salary $92K – $148K USD / year
Type Full-Time
Experience mid
Exp. Years Not specified
Education Not specified
Category QA & Testing

Johnson & Johnson is seeking a Software Design Quality Engineer II to support medical device software development, risk management, and cybersecurity efforts within their MedTech division.

  • Support software design and development
  • Conduct risk management activities
  • Evaluate end user needs and standards
  • Drive risk analysis and hazard assessments
  • Maintain traceability and design verification

Role involves supporting software development lifecycle processes, risk management activities, cybersecurity, and design controls for healthcare products using Agile, Waterfall, and SAFe methodologies.

The ideal candidate is a mid-level quality engineer with experience in medical device software, risk management, and cybersecurity. They should have a strong understanding of design controls and product risk analysis within healthcare technology.

Software DesignSoftware Development LifecycleRisk ManagementCybersecurityDesign Controls
AgileWaterfallSAFeDevOpsTraceability
AgileWaterfallSAFeDevOps
Software DesignSoftware Development LifecycleAgileWaterfallSAFeDevOpsRisk ManagementCybersecurityDesign ControlsTraceabilityRisk Management PlansHazard AnalysesSFMEA
Software DesignSoftware Development LifecycleAgileWaterfallSAFeDevOpsRisk ManagementCybersecurityDesign ControlsTraceabilityRisk Management PlansHazard AnalysesSFMEA
CommunicationTeamworkAutonomyRisk-based decision makingSelf-motivated
Industry Healthcare & Medical
Job Function Quality assurance and risk management for medical device software
Role Subtype Quality Engineer
Tech Domains Cybersecurity, Active Directory, Microsoft 365, Azure, ISO 13485
Software DesignSoftware Development LifecycleAgileWaterfallSAFeDevOpsRisk ManagementCybersecurityDesign ControlsTraceabilityRisk Management PlansHazard AnalysesSFMEAQuality EngineerMedical DeviceRisk AnalysisDesign VerificationDesign ValidationProduct Risk ManagementISO 13485software designsoftware development lifecyclerisk managementcybersecuritydesign controlshazard analysismedical deviceproduct risk management

Lack of experience in medical device quality, No background in risk management or cybersecurity, No understanding of design controls or SFMEA

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