Associate II, Software Engineering

Summary of Position: Plan and coordinate software documentation changes per procedure, and in partnership with stakeholders. Assure 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.

Key

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.

Assure compliance with software release procedures for post-market changes. Key Requirements/Minimum

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 1