Associate Software Engineering

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.

Good 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.