Associate II, Software Engineering

Overview

Plan and coordinate post-production software documentation changes in partnership with stakeholders, and support software verification, validation, audit and regulatory activities for medical device software.

What you'll do

• Plan and coordinate software documentation changes per procedure, in partnership with stakeholders.
• Ensure updates are included in the designated document repository and the appropriate DHF.
• Collaborate with on-shore and off-shore Software Verification and Validation teams to supply inputs for test cycles and documentation updates after testing.
• Support audit, regulatory and other compliance activities by querying, analyzing and providing requested information.
• Update documentation as required for changes in regulatory requirements.
• Work closely with the Lake Forest software development team to support software development activities and associated deliverables.
• Prepare, coordinate and document post-production software deliverable updates per the master schedule in support of Software Development leads.
• Submit and monitor approval cycles for required deliverables.
• Maintain electronic software DHF and TFS repositories for documentation.
• Ensure compliance with software release procedures for post-market changes.

What you'll need

• Bachelor's in Computer Science, Software Development, MIS, BIS, or another related discipline with 2 years of experience; or 5 years of relevant experience.
• Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and internal customers.
• Some knowledge of ISO 14971 and ISO 13485 (or US 21 CFR 820.30) or systems engineering.
• Some knowledge of Software Development Lifecycle Management (SDLC).
• Good interpersonal and communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment.
• Experience with Microsoft Visual Studio, Azure DevOps (ADO), or other integrated development environment (IDE) tools.
• Intermediate Microsoft Word skills, including TOC, tables and macros.
• Excellent technical/scientific writing in English in a regulated environment.
• Superior verbal English communication skills in a remote environment.
• Microsoft Office Suite (Word, Excel, PowerPoint, Visio).

Nice to have

• Knowledge of IEC 62304.
• Experience with document management systems (preferred: PLM Windchill).
• Licenses and certifications: Medical Device Risk Management (ISO 14971), Medical Device Design Control (US 21 CFR 820.30), Medical Device Software LCM (IEC 62304).

Details

• Location: Bangalore, India.
• Work hours: 1 PM to 10 PM IST.
• Relocation assistance: Yes.