Design Control Engineer

Design Control Engineer Dandy is transforming the massive and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to achieve more for their practices, their people, and their patients. ABOUT THE ROLE The Design Controls Engineer (L5) will be the centralized owner of Dandy’s design control execution across hardware, materials, packaging, and software. Design activities at Dandy are distributed across EPD (software), operations, manufacturing engineering, product, and quality. This role ensures design control evidence (DHF/RMF/traceability/V&V) is consistently created and maintained for new products and changes - while working within the existing QMS change control process WHAT YOU’LL DO 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. DESIGN-CHANGE IMPACT ASSESSMENT (WITHIN QMS CHANGE CONTROL) - 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 INTEGRATION - Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk controls with verification evidence and traceability. - Ensure risk files are current and connected to design decisions, design reviews, and releases. VERIFICATION / VALIDATION AND DESIGN TRANSFER READINESS - Author and review verification and validation protocols/reports, including: - hardware/material validation (e.g., formulation/spec changes, packaging validation triggers) - software lifecycle documentation aligned to IEC 62304 expectations where applicable - Establish design transfer expectations linking development to manufacturing/release readiness (traceability through BOMs, process validation inputs, release documentation, and handoff criteria). CROSS-FUNCTIONAL LEADERSHIP + ENABLEMENT - Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and design-change documentation are integrated. - Coach internal teams (EPD, Ops, Product, Manufacturing Engineering) on design control expectations and “how we do it at Dandy,” using practical checklists and templates. AUDIT / INSPECTION READINESS AND DEFENSE - Serve as SME and key presenter during external audits (e.g., BSI) for design controls-related scope. - Defend Dandy’s design control approach and evidence during auditor questions; identify gaps and drive remediation plans to closure. - Implement and maintain the document/record structure for design evidence in the QMS (e.g., Dot Compliance) in partnership with QMS/Doc Control. WHAT WE’RE LOOKING FOR REQUIRED QUALIFICATIONS - 3+ years of experience in medical devices / life sciences with deep focus on design controls, V&V, and risk management (startup/scale-up experience strongly preferred). - Proven track re ... (truncated, view full listing at source)