Senior Principal Embedded Software Quality Lead (Medical Devices)

Baxter International; Raleigh (NC); On-site; USD 128,000 - 176,000; Full time

Job summary

Baxter International in Raleigh, NC seeks a Senior Principal Engineer, Software Design Quality to serve as a senior technical authority for software design quality across the product lifecycle. The focus is embedded software in electromechanical medical devices, with potential PC/web/software support as needed.

You will lead risk-based quality strategies, ensure compliance with FDA, ISO standards, and design controls, and mentor engineers while guiding release decisions across dispersed teams.

Qualifications

• Comprehensive knowledge of 21 CFR 820.30 - Design Controls and applicable regulatory requirements.
• Ability to apply risk-based decision making across software development and maintenance.
• Experience with software requirements engineering, allocation, and traceability.
• Proficient in software configuration management, change control, and release management.
• Experience with embedded software for regulated medical devices; PC/web/connected software desirable.
• ASQ Certified Quality Engineer or equivalent experience desired.
• 8+ years in software quality engineering, particularly for medical device software.
• Advanced training or certification in software quality, cybersecurity is a plus.

Responsibilities

• Serve as senior Design Quality authority across full product lifecycle.
• Provide Design Quality oversight for embedded software in electromechanical medical devices.
• Lead risk-based quality strategies aligned with use, architecture, and regulations.
• Enforce FDA, ISO, IEC standards, design controls, and lifecycle processes.
• Mentor Design Quality engineers and promote scalable best practices.
• Support audits, regulatory inspections, and submissions with objective evidence.
• Lead or influence release-readiness decisions with risk-based justification.
• Coordinate cross-functional teams across distributed sites.

Skills

Design Controls

Risk-based decision making

Requirements engineering

Software configuration management

Embedded software quality

ASQ CQE desirable

Engineering degree required

Software quality/cybersecurity

Experience in regulated software

Education

Bachelor's or Master's in Software Engineering, CS, CE, EE or related

Tools

AI analytics tools

Job description

Baxter International in Raleigh, NC seeks a Senior Principal Engineer, Software Design Quality to serve as a senior technical authority for software design quality across the product lifecycle. The focus is embedded software in electromechanical medical devices, with potential PC/web/software support as needed.

You will lead risk-based quality strategies, ensure compliance with FDA, ISO standards, and design controls, and mentor engineers while guiding release decisions across dispersed teams.