Company:A Large Global Organization

Key Skills: Documentation, Medical Device, Design, ISO, SDLC, ISO 13485, ISO 14971, IEC 62304, 21 CFR, DHCP

Roles and Responsibilities:
Prepare, coordinate, track, and document post-production software deliverables and documentation updates according to the master schedule.
Maintain electronic software DHF records and associated document repositories, ensuring approved content is complete, current, and properly controlled.
Coordinate with software development and Software Verification and Validation teams to provide inputs for test cycles and incorporate resulting documentation updates.
Support audits, regulatory activities, and compliance reviews by retrieving, analyzing, and presenting requested technical and quality information.
Monitor approval workflows and confirm compliance with software release procedures for post-market changes.

Skills Required:
2 - 4 years of relevant experience in software engineering, software documentation, medical devices, quality systems,



or regulated product development.
Working knowledge of ISO standards, medical device software documentation, design controls, and software development lifecycle processes.
Ability to support regulated software development deliverables, document control activities, and electronic DHF maintenance.
Understanding of software verification, validation, release documentation, and compliance requirements for medical device products.
Experience with document management systems, software repositories, Microsoft Word, and Microsoft Office tools; familiarity with Visual Studio, Azure DevOps, or comparable IDE and development management tools is beneficial.

Positive to Have:
DHCP, ISO 13485, ISO 14971, IEC 62304, and 21 CFR knowledge.

Education: B.E. or B.Tech in Computer Science, Software Development, MIS, BIS, or a related discipline.

📌 Associate Software Engineering Bengaluru
🏢 MyCareernet
📍 Bengaluru