About this role
This role involves leading design quality assurance activities for new and sustaining medical device projects, ensuring compliance with regulatory standards and robust risk management.
Key Responsibilities
- Lead QA for product development
- Manage risk processes
- Review system architecture
- Conduct design verification and validation
- Lead cross-functional teams
Technical Overview
Focuses on hardware/software systems architecture, design verification and validation, risk management, and design controls within the medical device industry.
Ideal Candidate
The ideal candidate is a senior design quality engineer with over 10 years of experience in medical device product development, specializing in hardware/software systems, risk management, and design validation. They demonstrate leadership in cross-functional teams and expertise in design controls.
Must-Have Skills
Experience leading design quality assurance for medical devicesKnowledge of risk management and design controlsExperience with hardware/software systems architectureFamiliarity with design verification and validation
Nice-to-Have Skills
Experience with usability testingExperience with software validationKnowledge of design standards
Tools & Platforms
Design Control ToolsRisk Management ToolsFMEA SoftwareDesign Verification and Validation Tools
Required Skills
Design Quality AssuranceProduct DevelopmentMedical Electrical EquipmentRisk ManagementDesign Change AnalysisDesign InputsDesign OutputsTest Method DevelopmentDesign VerificationDesign ValidationUsability TestingSW ValidationProcess ValidationLabelingHardware/Software Systems ArchitectureFailure Mode and Effects AnalysisdFMEApFMEA
Hard Skills
Design Quality AssuranceProduct DevelopmentMedical Electrical EquipmentRisk ManagementDesign Change AnalysisDesign InputsDesign OutputsTest Method DevelopmentDesign VerificationDesign ValidationUsability TestingSW ValidationProcess ValidationLabelingHardware/Software Systems ArchitectureFailure Mode and Effects AnalysisdFMEApFMEA
Soft Skills
LeadershipCross-functional CollaborationCommunicationProblem-solvingTeamwork
Keywords for Your Resume
Design Quality AssuranceProduct DevelopmentMedical Electrical EquipmentRisk ManagementDesign Change AnalysisDesign InputsDesign OutputsTest Method DevelopmentDesign VerificationDesign ValidationUsability TestingSW ValidationProcess ValidationLabelingHardware/Software Systems ArchitectureFailure Mode and Effects AnalysisdFMEApFMEA
Deal Breakers
Lack of experience in medical device design QA, No familiarity with risk management tools, Inability to lead cross-functional teams
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