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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