Senior Design Quality Engineer

iRhythm Technologies, Inc.

. Support product development teams from concept through commercialization and post-market evaluation .

Posted 9/24/2026full-timeSan Francisco • California • United StatesSenior💰 $138,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Quality Assurance for medical devices, with a strong focus on design control, risk management, and compliance with international standards. Proficient in leading verification and validation activities while supporting product development from concept to commercialization.

Highest-signal resume keywords

Quality Assurance ExperienceDesign Control ExpertiseRisk Management Proficiency21 CFR 820 ComplianceISO13485 Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Embedded Software DevelopmentDesign VerificationDesign ValidationTechnical Report WritingRisk AssessmentTraceability Matrix DevelopmentElectromechanical Systems UnderstandingDesign Input/Output DefinitionQuality System NavigationRegulatory Compliance

Soft Skills

Problem SolvingCollaborationCommunicationLeadership

Tools & Technologies

JiraMaster ControlJAMADocumentation ToolsDefect Tracking ToolsTest Management Tools

Industry Keywords

Medical Device21 CFR 820ISO13485ISO14971IEC 62304Design History FilePost-Market EvaluationInternal AuditsExternal AuditsQuality Assurance Standards

About the role

Key responsibilities & impact

Support product development teams from concept through commercialization and post-market evaluation
Provide technical engineering support for hardware, firmware, and stand-alone software product development projects
Provide expertise and guidance on design control and risk management
Plan and execute design controls, risk management, and design verification and validation
Support development of product design history files and compliance with internal processes, standards, and regulations
Define design inputs, design outputs, and traceability matrices with engineering
Develop product risk management files and assess user, design, process, and supplier risks
Review design architectures, selections, requirements, and drawings from early design concepts
Assess validation requirements, solve test-related problems, and develop preventive strategies
Lead risk assessments supporting verification and validation activities
Assess, plan, verify, validate, and document design changes
Produce technical reports supporting product changes or quality assurance investigations
Support internal and external audits, including preparation and direct interaction with auditors
Perform other quality-related duties as assigned

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering
Minimum of 5 years of experience in Quality Assurance of class II or III products with embedded software in the medical device field
Demonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards
Solid understanding of design control and risk management from early design and development through commercialization
Demonstrated experience with electromechanical systems from concept through launch is preferred
Proficiency in using tools for documentation, defect tracking, and test management (e.g., Jira)
Able to navigate the quality system with minimal oversight on projects
Demonstrated competency of IEC 62304 and other international standards
Experience using Master Control, Jira, and JAMA is preferred

Benefits

Comp & perks

Hybrid work arrangement
Reasonable accommodations for qualified individuals with disabilities in job application procedures