What are the responsibilities and job description for the SaMD (Software as a Medical Device) Development Consultant - Santa Clara, CA (Hybrid) position at R Systems, Inc.?
Job Details
Key Responsibilities:
- Assess & Optimize Software Development Processes
- Review current SDLC, QMS, DevOps, and AI integration strategies.
- Identify gaps in compliance, cybersecurity, and automation.
- Improve bug-fixing, hotfix management, and feature development workflows.
- Regulatory & Compliance Evaluation
- Ensure alignment with FDA, IEC 62304, ISO 13485, HIPAA, GDPR.
- Assess software validation, post-market surveillance, and risk management.
- Tool & Metrics Optimization
- Evaluate development tools and suggest improvements.
- Define key performance indicators (KPIs) to track software quality.
- Team & Vendor Assessment
- Analyze team structure, skill sets, and third-party vendor capabilities.
- Ensure external partners align with long-term development goals.
- Deliver Reports & Recommendations
- Provide a comprehensive assessment report with prioritized action items.
- Develop a roadmap for process improvements and investment strategies.
Key Requirements:
Experience in SaMD development, software quality, and regulatory compliance
Strong knowledge of IEC 62304, ISO 13485, FDA 21 CFR Part 820, HIPAA, GDPR
Expertise in software development best practices (TDD, BDD, DevOps, CI/CD)
Knowledge of cybersecurity frameworks (ISO 27001, NIST)
Experience in AI/ML integration, cloud technologies (AWS, Azure, Google Cloud Platform)
Ability to assess software tools, QMS, and third-party vendor capabilities
Excellent communication & stakeholder engagement skills
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