Associate II, Software Engineering
Core
Plan and coordinate software documentation changes, manage document repositories, and support audit/regulatory compliance for medical device software.
Role type
Associate II, Software Engineering (Documentation & Compliance)
Builds
Electronic software DHF and TFS repositories, post-production software deliverable updates
Domain
Medical Device Software / Regulatory Compliance
Required skills
Software Development Lifecycle Management (SDLC), Document Management Systems, Microsoft Visual Studio, Azure DevOps, Technical/Scientific Writing in English, Microsoft Word (TOC, tables, macros)
Preferred skills
ISO 14971, ISO 13485, IEC 62304, PLM Windchill, Medical Device Risk Management, Medical Device Design Control
Technologies
Microsoft Visual Studio, Azure DevOps (ADO), PLM Windchill, Microsoft Office Suite
Responsibilities
Plan and coordinate software documentation changes per procedure; Collaborate with Software Verification and Validation teams for test cycles; Support audit, regulatory, and compliance activities; Update documentation for regulatory requirement changes; Maintain electronic software DHF and TFS repositories
Seniority
Associate II, 2+ years experience