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