Dandy · 7 hours ago
Design Control Engineer
United States
Full-time
Remote
Mid Level
3+ years expDandy is transforming the dental industry through technology and innovation. The Design Control Engineer will oversee design control execution across hardware, materials, packaging, and software, ensuring compliance with quality management standards and facilitating cross-functional collaboration.
Artificial Intelligence (AI)CADDentalHealth CareIndustrial AutomationLogisticsManufacturingSoftware
Responsibilities
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
Ensure risk files are current and connected to design decisions, design reviews, and releases
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)
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
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
Qualification
Required
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 record building and operating design control frameworks in environments where development is distributed across multiple teams
Strong working knowledge of: ISO 13485 (design & development controls, design changes), FDA 21 CFR 820 design controls expectations, ISO 14971 risk management, IEC 62304 software lifecycle evidence (where applicable)
Demonstrated ability to lead cross-functional design reviews, drive decisions, and create audit-ready DHFs/RMFs
Excellent technical writing and documentation discipline; able to translate requirements into pragmatic templates and checklists teams will actually use
20% domestic travel
Preferred
Prior experience supporting external audits or inspections as the design controls SME
ASQ CQE/CQA, ISO 13485 Lead Auditor, or related certifications preferred (not required)
Benefits
Healthcare
Dental
Mental health support
Parental planning resources
Retirement savings options
Generous paid time off
Company
Dandy
More than a dental lab—Dandy is a tech-powered, end-to-end solution delivering high-quality, customized restorations at scale.
501-1000 employees
H1B Sponsorship
Dandy has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
General Catalyst,GreenoaksGeneral Catalyst,Human CapitalGreenoaks
2025-05-02Series D
2022-08-17Series C
2022-01-20Series B
Leadership Team
Daniel Hanover
Co-Founder, Chief Executive Officer, Chief Technology Officer
Toni Oloko
Co-Founder
Recent News
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