Senior Software Architect & Compliance Lead (FDA/IEC 62304)

Real; Minneapolis (MN); On-site; USD 150,000 - 230,000; Full time

Job summary

Real in Minneapolis, MN, is seeking a Principal Software Engineer focused on compliance for a breakthrough medical technology. You’ll lead software lifecycle activities, assess IEC 62304 compliance, and guide documentation while collaborating with regulatory, risk, and engineering teams.

You will drive verification/validation strategy, manage defects, and shape architecture roadmaps for scalable, secure software in a fast-paced, multidisciplinary environment.

Qualifications

• Bachelor’s degree in Software Engineering, CS, EE, or related field.
• 10+ years software development, 5+ years in regulated medical devices.
• Deep IEC 62304 expertise and lifecycle processes.
• Hands-on with compliance documentation.
• Experience with ISO 14971 risk management.
• Proven V&V leadership in complex programs.
• Strong architecture and system design capabilities.
• Experience integrating AI-enabled tools into workflows.

Responsibilities

• Assess software against IEC 62304 and define safety classifications.
• Perform gap analyses and establish compliant development processes.
• Create and maintain SDP, SRS, SAD, and DFMEA docs.
• Maintain requirements traceability across lifecycle.
• Collaborate with Quality/Regulatory for global submissions.
• Act as SME for software lifecycle compliance and design controls.
• Lead software risk management per ISO 14971 and IEC 62304.
• Define and maintain V&V strategies; ensure traceability to tests.
• Review unit/integration/system test strategies and results.
• Oversee defect management, regressions, and release qualification.
• Collaborate with Human Factors and Safety teams on risk mitigation.
• Define architecture and roadmaps; address scalability and cybersecurity.
• Coordinate external partners while ensuring design control.
• Report progress and risks to leadership and stakeholders.

Skills

IEC 62304

AI/ML

Software Lifecycle

V&V Planning

Software Architecture

Regulatory Documentation

Education

Bachelor’s degree in Software Engineering or related field

Tools

Python

C

C++

Job description

Real in Minneapolis, MN, is seeking a Principal Software Engineer focused on compliance for a breakthrough medical technology. You’ll lead software lifecycle activities, assess IEC 62304 compliance, and guide documentation while collaborating with regulatory, risk, and engineering teams.

You will drive verification/validation strategy, manage defects, and shape architecture roadmaps for scalable, secure software in a fast-paced, multidisciplinary environment.