Senior Principal Software Engineer - Compliance Strategist

Real Staffing; Minneapolis (MN); On-site; USD 140,000 - 190,000; Full time

Job summary

Real Staffing is seeking a Principal Software Engineer - Compliance Lead in Minneapolis, MN to drive software compliance for a breakthrough medical technology. You will own software lifecycle documentation, lead verification and validation, and partner with Quality and Regulatory Affairs to support global submissions.

You’ll define architecture and roadmaps, manage risk per ISO 14971, IEC 62304, and collaborate with cross-functional teams including systems, clinical, and regulatory groups to

Qualifications

• Bachelor's degree in Software Engineering or related field.
• 10+ years of software development, including 5+ years in regulated medical device environments.
• Deep expertise with IEC 62304 and medical device software development lifecycle processes.
• Hands-on experience developing and maintaining software compliance documentation.
• Direct experience with software risk management under ISO 14971.
• Proven leadership of software verification and validation activities.
• Strong software architecture and systems design experience.
• Familiarity with integrating modern AI-enabled development tools into engineering workflows.
• Experience leading technical deliverables within complex, cross-functional organizations.
• Excellent written and verbal communication skills, including the ability to create regulatory-quality documentation and influence technical decisions.

Responsibilities

• Lead software compliance lifecycle management per IEC 62304 and ISO 14971.
• Define verification & validation strategies and ensure traceability throughout the lifecycle.
• Develop and maintain key software lifecycle documentation (SDP, SRS, SAD).
• Collaborate with Quality and Regulatory Affairs for global submissions.
• Oversee defect management, regression testing, and release qualification.
• Provide technical leadership and architecture direction for scalable, secure software.

Skills

Medical device software

Regulated environments

Software architecture

Leadership

Education

Bachelor's degree in Software Engineering or related field

Tools

Python

C

C++

Job description

Real Staffing is seeking a Principal Software Engineer - Compliance Lead in Minneapolis, MN to drive software compliance for a breakthrough medical technology. You will own software lifecycle documentation, lead verification and validation, and partner with Quality and Regulatory Affairs to support global submissions.

You’ll define architecture and roadmaps, manage risk per ISO 14971, IEC 62304, and collaborate with cross-functional teams including systems, clinical, and regulatory groups to