Job Description Summary

Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation.
Responsible for departmental operations planning/execution or is focused on execution of skilled activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results.
The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume,



timeliness etc.).
Job Description

Roles and Responsibilities

Ensure compliance with applicable medical device standards and regulations, including:
ISO 13485 (Quality Management Systems)
ISO 14971 (Risk Management)
IEC 62304 (Medical Device Software Lifecycle Processes)
IEC 62366 (Usability Engineering)
IEC 60601 Series (Medical Electrical Equipment Safety)
IEC 81001-5-1 (Health Software Cybersecurity)
FDA, MDR, and other global regulatory requirements as applicable
Drive design reviews and technical reviews across all phases of development, ensuring readiness for phase gates and regulatory submissions.
Partner with Verification & Validation teams to establish comprehensive V&V; strategies, ensuring designs are testable and requirements are fully traceable to objective evidence.
Oversee development and maintenance of Design History Files (DHF), system specifications, archite

📌 Lead System Designer (Bengaluru)
🏢 MS0230 GE Healthcare
📍 Bengaluru