Position : Python, SOUP, Cybersecurity, Medical / SOUP / Cybersecurity Lead and Validation Engineer
Job Description – Senior Software Engineer – Python | SOUP | Cybersecurity | Medical Devices
Position: Senior Software Engineer – Python (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
- Jenkins
- Docker
- SonarQube
- Black Duck, Snyk, or similar Software Composition Analysis (SCA) tools
Operating Systems
Regulatory & Compliance Knowledge
Strong understanding of:
- IEC 62304 – Medical Device Software Lifecycle
- ISO 14971 – Risk Management
- ISO 13485 – Quality Management Systems
- FDA 21 CFR Part 820
- FDA Cybersecurity Guidance
- AAMI TIR57 – Principles for Medical Device Security
- AAMI TIR97 – Medical Device Cybersecurity Management
- IEC 81001-5-1 – Health Software Cybersecurity
- SBOM requirements and vulnerability management
Preferred Experience
- Experience in the medical device or healthcare industry.
- Exposure to connected medical devices, embedded software, or cloud-enabled
healthcare applications.
- Experience with secure communication protocols and software integration.
- Familiarity with Python automation frameworks and DevSecOps practices.
- Experience supporting regulatory submissions and cybersecurity documentation.
Qualifications
- Bachelor's or Master's degree in Computer Science, Electronics, Biomedical
Engineering, Information Security, or a related engineering discipline.
- 6–10 years of experience in software development using Python.
- Experience working in a regulated medical device environment.
- Strong analytical, debugging, and problem-solving skills.
- Excellent communication and collaboration skills.
Nice to Have
- Experience with Embedded Linux or C/C++.
- Knowledge of DICOM, HL7, or FHIR.
- Experience with CI/CD and DevSecOps pipelines.
- ISTQB, CSSLP, CEH, or Security+ certification.
- Experience with cloud platforms (AWS, Azure) and container security.
Primary Skills
- Python
- SOUP (Software of Unknown Provenance)
- Medical Device Software Development
- Medical Device Cybersecurity
- Secure Software Development Lifecycle (SSDLC)
- IEC 62304
- ISO 14971
- ISO 13485
- FDA Cybersecurity Guidance
- SBOM
- OWASP
- Docker
- Git
- Jenkins
- Software Verification & Validation (V&V)
- Linux
