Software Developer

Job Title: Senior Software Engineer – Medical Device (Software Quality, Cybersecurity & ISO 13485)

Location: Bangalore, India

Employment Type: Full-Time

​We are seeking a Senior Software Engineer experienced in regulated medical device software development (SaMD and embedded systems). In this role, you will design, implement, and maintain mission-critical software while ensuring strict alignment with ISO 13485 quality systems, IEC 62304 lifecycles, and modern medical device cybersecurity standards.

​Key Responsibilities:​Software Development & Architecture: Design, write, test, and maintain robust, fault-tolerant code (C/C++, Python, or modern OOP languages) for safety-critical medical device applications.

​Cybersecurity Engineering: Implement secure coding practices, threat modeling (e.g., STRIDE), vulnerability management, cryptographic controls, and SBOM maintenance in accordance with FDA cybersecurity guidance and AAMI TIR57.

​Quality Management & Compliance: Ensure all software activities adhere to ISO 13485 Quality Management Systems, IEC 62304 (Medical device software lifecycle), and ISO 14971 (Risk management).

​V&V and Documentation: Author, execute, and maintain Design History Files (DHF), Software Requirements Specifications (SRS), Architecture Specifications, and automated Verification & Validation (V&V) test protocols.

​Audit & Regulatory Support: Support internal and external audits (FDA, Notified Bodies) by providing traceability analyses, design control evidence, and cybersecurity risk assessments.

​Qualifications

​Education: Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.

​Experience: 4+ years of professional software engineering experience, with at least 2 years in a regulated medical device environment.

​Standards & Regulations: Working knowledge of ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820 / QMSR.

​Cybersecurity: Demonstrated experience with threat modeling, penetration testing oversight, vulnerability scanning (SAST/DAST), and post-market cybersecurity monitoring.

​Tech Stack: Proficiency in one or more core languages (C++, C#, C, Python, or Java), automated unit/integration testing frameworks, and CI/CD pipelines.

​Preferred Qualifications:​Experience with Software as a Medical Device (SaMD) deployment in cloud environments (AWS/Azure/GCP) complying with HIPAA. ​Familiarity with IEC 81001-5-1 or AAMI TIR57 standards.​Certifications such as CISSP, CSSLP, or ASQ Software Quality Engineer (CSQE).

​To Apply: Submit your resume and a brief summary of your experience building software under ISO 13485/IEC 62304 to asroy@narayananethralaya.com