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 Responsibilities:
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 Qualifications:
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. Preferred knowledge of IEC 62304.
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 document management systems (preferred: PLM Windchill).
Experience with Microsoft Visual Studio, Azure DevOps (ADO), or other integrated development environment (IDE) tools.
Intermediate Microsoft Word skills, including TOC, tables, and macros
Knowledge, Skills, And Abilities
Personal Effectiveness Competencies
Project Excellence – Fundamental
Continuous Learning – Intermediate
Digital and Technology Savvy – Intermediate
Operational Excellence – Intermediate
Breakthrough Analysis – Intermediate
Organizational Savvy – Intermediate
Skills And Knowledge
STEAM (Science, Technology, Engineering, Arts, and Mathematics)
Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
Systems Engineering or Risk Management for Medical Devices (ISO 14971)
Medical Device Software Life Cycle Processes (IEC 62304)
Regulations and Guidelines
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)
Experience
Cross-Functional Collaboration – Primary
New Product Innovation – Secondary
Accountability – Primary
Influencing Without Authority – Primary
Managing Crisis – Secondary
Functional Breadth – Secondary
Licenses And Certifications (Preferred)
Medical Device Risk Management – ISO 14971
Medical Device Design Control – US 21 CFR 820.30
Medical Device Software LCM – IEC 62304(listed as IEC 62034 in the document, likely a typographical error)
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
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Work arrangement
Yes