Senior Principal Software Design Quality Engineer

Baxter International Inc.

. Serve as the senior Design Quality technical authority for medical-device software projects across the full product lifecycle .

Posted 11/9/2026full-timeUnited StatesSenior💰 $128,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Design Quality oversight for embedded software in electromechanical medical devices, ensuring compliance with FDA regulations and ISO standards while leading risk management and software verification strategies.

Highest-signal resume keywords

Design Quality OversightRisk-Based Decision MakingSoftware Requirements EngineeringSoftware Configuration ManagementQuality Engineering Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

21 CFR 820.30 - Design ControlsISO 13485ISO 14971IEC 62304Software Anomaly ManagementSoftware Verification and ValidationRoot-Cause AnalysisStatistical TechniquesEmbedded Software DevelopmentRisk Management

Soft Skills

Leadership SkillsCross-Functional CollaborationMentoring

Tools & Technologies

AI-Assisted Analytical ToolsConfiguration Management Tools

Certifications & Qualifications

ASQ Certified Quality EngineerAdvanced Training in Software Quality

Industry Keywords

Medical Device SoftwareQuality System RequirementsRegulatory CompliancePost-Market IssuesChange Control

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Serve as the senior Design Quality technical authority for medical-device software projects across the full product lifecycle
Provide Design Quality oversight primarily for embedded software in electromechanical medical devices
Provide independent Quality leadership for software development, sustaining engineering, design changes, and release decisions
Establish risk-based software Design Quality strategies
Ensure adherence to FDA regulations, ISO and IEC standards, design controls, software lifecycle processes, and Quality System requirements
Improve internal processes while maintaining quality standards
Oversee software lifecycle plans and deliverables from concept through retirement
Lead oversight of iterative releases, sustaining changes, defect corrections, cybersecurity updates, and documentation revisions
Evaluate software requirements and ensure end-to-end traceability
Lead software risk-management oversight, including hazard analysis, risk controls, traceability, and verification
Oversee software verification and validation strategies, acceptance criteria, coverage, and results
Oversee characterization, investigation, risk assessment, disposition, and closure of software anomalies and defects
Evaluate unresolved anomalies and testing issues for safety, effectiveness, compliance, and release readiness
Lead or support release-readiness assessments and escalate unresolved concerns
Oversee configuration management and design changes
Provide Design Quality expertise for complaints, nonconformances, CAPAs, trend investigations, field issues, and root-cause investigations
Evaluate defects, complaints, post-market signals, and released-product risks for corrective action or escalation
Lead resolution of complex cross-functional software quality issues and drive systemic improvements
Support audits, regulatory inspections, submissions, inquiries, and responses
Communicate Quality positions and technical risks to engineers, cross-functional partners, and senior leadership
Mentor Design Quality engineers and promote scalable best practices and continuous improvement

Requirements

What you’ll need

Completely proficient in 21 CFR 820.30 - Design Controls, ISO 13485, ISO 14971, IEC 62304, and applicable Quality System and regulatory requirements
Demonstrated ability to apply risk-based decision making throughout software development and maintenance
Completely proficient in software requirements engineering, including development, analysis, allocation, and traceability
Completely proficient in software anomaly and defect management
Completely proficient in software configuration management, including configuration identification, change control, status accounting, and release management
Completely proficient in product and process development concepts, including change control and risk management
Structured root-cause analysis, engineering judgment, risk evaluation, objective evidence, and appropriate statistical techniques
Proven leadership skills and ability to independently make and defend difficult software quality, safety, compliance, and release decisions
Extensive experience leading and influencing geographically distributed cross-functional teams without direct authority
Extensive experience providing Design Quality oversight for embedded software in regulated electromechanical medical devices
Experience assessing software defects and post-market issues for correction, removal, field action, or escalation
Experience utilizing AI-assisted and advanced analytical tools with appropriate human oversight within Software Quality
ASQ Certified Quality Engineer or equivalent experience desired
Bachelor’s or Master’s Degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or related engineering/scientific discipline
Advanced training or certification related to software quality, cybersecurity, or medical-device software quality desired
Overall 8+ years of Quality Engineering experience
Minimum 5+ years supporting software-centric projects
Experience with embedded medical-device software, iterative or sustaining releases, defect corrections, requirements and risk-documentation updates, and post-market or release decisions
Must be authorized to work for any employer in the U.S.; visa sponsorship is unavailable

Benefits

Comp & perks

Relocation assistance provided
Flexible workplace policy with onsite collaboration
Medical and dental coverage starting on day one
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with discounted company stock
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
Discretionary bonuses may be available