AILLM Application Architect

Job Title

Job Description

Job title:
As an important member of the R&D team the AI/LLM Application Architect will lead the architecture governance and technical strategy of a controlled AI Harness platform for medical-device R&D. The role is responsible for enabling AI-assisted quality and engineering workflows across requirements traceability DHF risk validation and change-impact analysis while ensuring the platform remains compliant auditable and verifiable under medical-device quality system expectations.

Your role:

• Lead the end-to-end architecture of the AI R&D QMS Harness including enterprise data access knowledge/RAG layers prompt and model governance AI workflow services audit logging and evidence archiving.

• Define system boundaries approved data classes model whitelisting prompt governance and human-in-the-loop controls so that AI outputs can be used in a controlled quality-system environment.

• Design and govern the core AI agents for Requirement Quality Traceability DHF/Evidence DFMEA/Risk Compliance Review Defect Impact and Review/Test workflows.

• Translate business and QMS requirements into scalable secure and validated application architecture across source systems such as ALM ClearQuest Windchill SOP repositories and DHF repositories.

• Establish technical controls for source citation no-source labeling RBACversion control logging and reproducibility of AI outputs.

• Partner with QA RA Risk Systems Engineering Validation and IT teams to define AI Use SOPs risk assessments OQ/PQ strategy and validation evidence required for deployment.

• Lead technical qualification of AI use cases through URS OQ PQ prompt validation regression testing and controlled change management.

• Define the target operating model for AI/LLM development including central harness team structure SME enablement model and deployment strategy by geography.

• Evaluate model providers orchestration frameworks RAG patterns and deployment options for cloud and local/private inference.

• Drive the long-term roadmap for controlled AI in R&D quality systems and create reusable architectural patterns for future expansion.

Youre the right fit if:

• You have acquired 8 years of experience in enterprise software AI/ML platform engineering LLM applications or regulated systems architecture preferably in medical devices healthcare life sciences or other regulated industries.

• Your skills include strong experience with AI/LLM application architecture RAG systems prompt and model governance API integration secure enterprise system design and audit-ready solution design.

• You have hands-on experience with Python and modern AI application stacks plus experience with enterprise AI platforms such as Azure OpenAI AWS Bedrock or equivalent controlled environments.

• You understand how to architect human-in-the-loop workflows evidence capture and quality gates for AI-assisted systems.

• You have working knowledge of regulated development and quality frameworks such as ISO 13485 IEC 62304 ISO 14971 FDA 21 CFR Part 820/11 or comparable standards.

• You can explain complex technical and governance concepts clearly to non-specialists senior stakeholders and cross-functional quality teams.

• You are comfortable leading cross-functional design reviews aligning architecture decisions with QA/RA expectations and shaping the validation strategy of AI-enabled workflows.

Preferred qualifications:

• Bachelors Masters or Ph.D. in Computer Science Software Engineering AI/ML Biomedical Engineering or a related field.

• Experience in medical imaging QMS tooling DHF workflows or regulated engineering environments is strongly preferred.

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