Senior Principal Software Design Quality Engineer (Medical Devices)

Location: Raleigh, North Carolina, or Round Lake, Illinois; flexible workplace policy with a required minimum number of onsite days per week. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Estimated base salary: $128,000–$176,000 annually, with possible discretionary bonuses.

Company

hirify.global develops healthcare products and technologies focused on saving and sustaining lives.

What you will do

• Serve as the senior Design Quality technical authority for software medical-device projects throughout the product lifecycle.
• Provide independent Quality oversight for embedded software in electromechanical devices and, as needed, PC-based, web-based, connected, and interoperable software.
• Establish risk-based Design Quality strategies aligned with intended use, architecture, development methods, and regulatory expectations.
• Oversee requirements, traceability, risk management, verification and validation, configuration management, releases, sustaining changes, and defect corrections.
• Assess anomalies, complaints, post-market signals, failed testing, and unresolved risks for correction, field action, escalation, and release readiness.
• Support audits, inspections, submissions, investigations, cross-functional quality decisions, mentoring, and systemic process improvements.

Requirements

• 8+ years of Quality Engineering experience, including substantial regulated software Design Quality experience and at least 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.
• Complete proficiency in 21 CFR 820.30 Design Controls, ISO 13485, ISO 14971, IEC 62304, Quality System requirements, and applicable medical-device software regulations.
• Complete proficiency in software requirements engineering, anomaly and defect management, configuration management, release management, change control, and risk management.
• Ability to apply risk-based decision making, structured root-cause analysis, engineering judgment, statistical techniques, and objective evidence to complex issues.
• Proven leadership and ability to independently make and defend difficult software quality, safety, compliance, and release decisions.
• Experience leading and influencing geographically distributed cross-functional teams without direct authority.
• Bachelor’s or Master’s degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related engineering or scientific discipline.
• Experience using AI-assisted and advanced analytical tools with appropriate human oversight within Software Quality.

Nice to have

• Experience with PC-based, web-based, connected, or interoperable medical-device software.
• ASQ Certified Quality Engineer or equivalent experience.
• Advanced training or certification in software quality, cybersecurity, or medical-device software quality.

Culture & Benefits

• Flexible workplace policy supporting collaboration through required onsite attendance.
• Full-time employment with medical, dental, life, disability, retirement, ESPP, paid time off, paid holidays, parental leave, educational assistance, and other U.S. benefits.
• Work with geographically dispersed, cross-functional teams in a culture emphasizing courage, trust, collaboration, ownership, and accountability.