Remote: Medical-Device Software QA & Regulatory Engineer

Capital Numbers Infotech; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Capital Numbers Infotech seeks a Senior Medical Device Software Quality & Regulatory Engineer to own design controls and V&V for an ISO 13485/QMSR compliant software project in a regulated environment. You will manage FDA 510(k) submissions, software documentation, and SBOM/SOUP management, coordinating with RA/QA and Restor3d teams.

The role emphasizes risk management, cybersecurity documentation, usability engineering, and cross-functional collaboration across time zones in a remote contract

Qualifications

• 5+ years in medical-device software development, quality, or regulatory, including at least one Class II (ideally Class III) device through design controls and FDA 510(k)
• Hands-on IEC 62304 deliverables across full life cycle for Class C software
• ISO 14971 risk management for software
• Experience with 21 CFR 820.30 design controls and ISO 13485 / QMSR
• Experience preparing software documentation for FDA 510(k) submissions
• Software V&V expertise with traceability matrices
• Cybersecurity documentation per FDA guidance
• HFs/usability engineering familiarity (IEC 62366-1)
• Ability to review Python/C++ Linux codebase and discuss with developers
• Strong technical writing and DHF maintenance
• Excellent communication with RA/QA teams across time zones

Responsibilities

• Establish and run the software design-control process per 21 CFR 820.30 / QMSR / ISO 13485
• Own IEC 62304 life-cycle documentation and software classification
• Plan and drive software V&V, write protocols/reports, ensure traceability
• Support ISO 14971 risk management and risk file contributions
• Manage SOUP and SBOM: version-pinning and anomalies
• Prepare cybersecurity documentation per FDA premarket guidance
• Contribute to human factors/usability inputs for surgeon workflows
• Assemble FDA 510(k) documentation within the Design History File
• Lead design reviews, configuration management, and issue resolution
• Interface with US device manufacturer's RA/QA teams across time zones

Skills

IEC 62304

ISO 14971

21 CFR 820 / QMSR

Regulatory submissions (510(k))

V&V planning & execution

Software design controls

Cybersecurity documentation

Risk management for software

Human factors/usability engineering

Technical writing & DHF

Python/C++/Linux codebase review

Cross-functional communication

Job description

Capital Numbers Infotech seeks a Senior Medical Device Software Quality & Regulatory Engineer to own design controls and V&V for an ISO 13485/QMSR compliant software project in a regulated environment. You will manage FDA 510(k) submissions, software documentation, and SBOM/SOUP management, coordinating with RA/QA and Restor3d teams.

The role emphasizes risk management, cybersecurity documentation, usability engineering, and cross-functional collaboration across time zones in a remote contract