✦ Luna Orbit — Science & Research

Sr. Design Quality Engineer- Shockwave Medical

at Johnson & Johnson

📍 Santa Clara, California, United States of America Unknown 💰 $91K – $147K USD / year Posted March 20, 2026
Salary $91K – $147K USD / year
Type Not Specified
Experience mid
Exp. Years Not specified
Education Not specified
Category Science & Research

This role involves verifying and validating hardware and embedded software for medical devices, ensuring compliance with industry standards and supporting product development.

  • Perform hardware verification
  • Conduct software validation
  • Ensure compliance with medical standards
  • Support design assurance activities
  • Collaborate with cross-functional teams

The position requires expertise in hardware and software verification, validation processes, and medical device regulatory standards such as FDA and ISO 13485.

The ideal candidate is a mid-level quality engineer with experience in hardware and software verification and validation for medical devices. They should be familiar with regulatory standards and have strong attention to detail.

Quality EngineeringHardware VerificationSoftware ValidationMedical Device Development
Embedded SoftwareHardware System DesignRegulatory Compliance
Verification & Validation SoftwareDesign Control Tools
Quality EngineeringHardware VerificationSoftware ValidationMedical Device DevelopmentDesign Assurance
Quality EngineeringEmbedded SoftwareHardware System VerificationValidationMedical Device DevelopmentDesign Assurance
CollaborationAttention to detailProblem-solvingCommunicationTeamwork
Industry Healthcare & Medical
Job Function Hardware and software verification and validation for medical devices
Role Subtype Healthcare & Medical
Tech Domains Medical Device Development, Quality Assurance
Quality EngineeringHardware VerificationSoftware ValidationMedical DeviceDesign AssuranceEmbedded SoftwareHardware SystemVerification & ValidationMedical Device DevelopmentDesign ControlRegulatory ComplianceRisk ManagementISO 13485FDA RegulationsQuality Systemquality engineeringhardware verificationsoftware validationmedical devicedesign assuranceembedded softwarehardware systemverification and validationregulatory compliancerisk management

Lack of experience in medical device verification, No familiarity with regulatory standards (FDA, ISO 13485)

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