SOUP Validation Engineer at Agiliad in Pune(Pune Station)

Job Description Senior Software Engineer Python | SOUP | Cybersecurity | Medical Devices

Experience: 6–10 Years

Location: Pune

Domain: Medical Devices

Job Summary

We are seeking an experienced Senior Software Engineer with expertise in Python, SOUP (Software of Unknown Provenance), Cybersecurity, and Medical Device Software Development. The ideal candidate will contribute to the design, development, risk assessment, and maintenance of medical device software while ensuring compliance with global regulatory standards and cybersecurity requirements.

The role involves developing Python-based applications and tools, managing third-party software components (SOUP), implementing secure software development practices, performing software verification and validation, and collaborating with cross-functional teams to deliver safe, reliable, and compliant medical device products.

Key Responsibilities
• Design, develop, and maintain software applications and utilities using Python for medical device products. 
• Evaluate, integrate, and manage SOUP (Software of Unknown Provenance) components in accordance with IEC 62304 requirements. 
• Perform SOUP risk assessments, impact analysis, vulnerability tracking, licensing reviews, and lifecycle management. 
• Develop and implement cybersecurity features aligned with secure software development practices. 
• Conduct threat modeling, software security assessments, and vulnerability analysis. 
• Support secure software architecture, authentication, encryption, and secure communication mechanisms. 
• Develop automation scripts and internal engineering tools using Python. 
• Collaborate with Systems Engineering, Quality Assurance, Regulatory, Clinical, and Product Security teams. 
• Participate in software design reviews, code reviews, and technical risk assessments. 
• Perform unit testing, integration testing, software verification, and validation activities. 
• Investigate software defects, perform root cause analysis, and implement corrective actions. 
• Prepare software design documentation, cybersecurity documentation, SOUP assessments, and regulatory deliverables. 
• Ensure complete traceability between requirements, design, implementation, testing, and risk management activities.

Required Technical Skills

Programming
• Python (Mandatory) 
• Object-Oriented Programming 
• Multithreading 
• REST APIs 
• Scripting and Automation

Medical Device Software
• Medical Device Software Development 
• Software Verification & Validation (V&V) 
• Requirements Traceability 
• Design Controls 
• Risk Management

SOUP (Software of Unknown Provenance)
• SOUP Assessment & Documentation 
• Third-Party Software Evaluation 
• Open-Source Software Compliance 
• Software Bill of Materials (SBOM) 
• Dependency and Vulnerability Management 
• License Compliance

Cybersecurity
• Secure Software Development Lifecycle (SSDLC) 
• Threat Modeling 
• Secure Coding Practices 
• Static & Dynamic Code Analysis 
• Authentication & Authorization 
• Encryption (TLS, AES, RSA) 
• Vulnerability Assessment & Remediation 
• CVE Analysis 
• Secure Boot and Firmware Security (preferred) 
• OWASP Secure Coding Principles 
• Medical Device Cybersecurity

Development Tools
• Git 
• GitHub/GitLab