Job Summary :
Seeking an experienced Software Development Team Lead to guide a cross-functional team in developing software for a next-generation diagnostic ECG system. This role requires expertise in software engineering, medical device standards (IEC 62304, ISO 14971, ISO 13485), and leadership in regulated product development.
Key Responsibilities :
Leadership & Project Management :
Lead a cross-functional team (embedded, desktop, cloud, AI / ML).
Plan and execute software development activities following IEC 62304 and ISO 13485 compliant processes.
Collaborate with QA, RA, and Risk Management teams for documentation and audits.
Manage sprint planning, backlog grooming, and milestone tracking in Agile / Scrum / Kanban environments.
Technical Oversight :
Design system and software architecture (real-time constraints, security, regulatory needs).
Guide implementation using C / C++, .NET (C#), and Python.
Lead integration of APIs, UI / UX, databases, and communication layers.
Supervise Linux-based development (scripting, system tools, deployment).
Regulatory & Quality : Ensure compliance with medical device software development standards (IEC 62304, ISO 14971, ISO
Collaborate with QA for software quality practices (code review, static analysis, unit testing, CI / CD).
Work with Risk Managers for hazard analysis, traceability, and risk mitigations.
AI / ML Awareness : Coordinate with AI / ML engineers for model deployment (embedded or cloud).
Support integration of signal processing and machine learning components in ECG analysis. Required Qualifications :
Education : Bachelor's or Masters degree in Computer Science, Electronics, Biomedical Engineering, or related field.
Experience : 6+ years of professional software development experience.
2+ years in a team lead or project lead role.
Experience with Linux-based development and system administration.
Strong hands-on experience with : .NET (C#) for desktop apps or services. Python for scripting, automation, and ML integration. Embedded C / C++ for low-level development.
Technical Skills : Familiarity with APIs (REST, gRPC), MQTT, JSON / XML.
Soft Skills : Excellent problem-solving, communication, and documentation skills. Desirable Skills :
Prior experience in a regulated environment (medical devices, avionics, automotive).
Knowledge of tools : Git, GitHub, GitLab CI, Jenkins, JIRA, Confluence.
Exposure to AI / ML model development or integration (e.g., TensorFlow Lite, Edge Impulse).
Understanding of cybersecurity standards (e.g., FDA Cybersecurity Guidance, ISO / IEC Experience managing offshore or remote development teams.
Software Development Team Lead • India