• Build and own design controls execution (HW + SW) • Establish and maintain Dandy’s Design & Development procedures (ISO 13485 §7.3) and supporting templates: Design Plans, Design Inputs/Outputs, Design Reviews, V&V plans, and DHF structures for both hardware and software. • Define a scalable DHF / design evidence model that fits Dandy’s distributed development structure and multi-site operations. • For every relevant change (software feature release, hardware/material spec change, packaging change, labeling/IFU change), own the design-change impact assessment: what DHF/RMF/traceability/V&V updates are required and what evidence must be created. • Ensure design-change work is executed through the established QMS change control workflow, including proper linkage to controlled documents, records, and training impacts where applicable. • Partner closely with Regulatory and Quality to flag when design changes may affect regulatory commitments and require additional documentation or testing. • Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk controls with verification evidence and traceability. • Author and review verification and validation protocols/reports • Establish design transfer expectations linking development to manufacturing/release readiness (traceability through BOMs, process validation inputs, release documentation, and handoff criteria). • Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and design-change documentation are integrated. • Serve as SME and key presenter during external audits for design controls-related scope. • Implement and maintain the document/record structure for design evidence in the QMS