Design Control Engineer

Dandy

5h

About The Position

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

Requirements

• 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

Nice To Haves

• 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).

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.
• 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.

Benefits

• For full-time positions, Dandy offers a wide range of best-in-class, comprehensive, and inclusive benefits tailored to each country where we operate.
• Our local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off—ensuring our team members are supported no matter where they live and work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed