Dandy is hiring a Design Control Engineer (L5) to be the centralized owner of design control execution across hardware, materials, packaging, and software. This role ensures design control evidence is consistently created and maintained for new products and changes within our established QMS framework.
What You'll Do
- Build and own design controls execution for hardware and software.
- Establish and maintain Dandy’s Design & Development procedures per ISO 13485 §7.3 and supporting templates.
- Define a scalable DHF/design evidence model for our distributed development structure and multi-site operations.
- Own the design-change impact assessment for every relevant change.
- Ensure design-change work is executed through the established QMS change control workflow.
- Partner closely with Regulatory and Quality to flag when design changes may affect regulatory commitments.
- Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk controls.
- Author and review verification and validation protocols and reports.
- Establish design transfer expectations linking development to manufacturing and release readiness.
- Lead cross-functional design reviews across hardware, software, and material development teams.
- Coach internal teams on design control expectations and practical checklists and templates.
- Serve as subject matter expert and key presenter during external audits for design controls-related scope.
- Defend Dandy’s design control approach and evidence during auditor questions.
- Implement and maintain the document and record structure for design evidence in the QMS.
What We're Looking For
- 3+ years of experience in medical devices or life sciences with deep focus on design controls, V&V, and risk management.
- Startup or scale-up experience strongly preferred.
- Proven track record building and operating design control frameworks where development is distributed across multiple teams.
- Strong working knowledge of ISO 13485, FDA 21 CFR 820 design controls, ISO 14971 risk management, and IEC 62304 software lifecycle evidence.
- Demonstrated ability to lead cross-functional design reviews, drive decisions, and create audit-ready DHFs and RMFs.
- Excellent technical writing and documentation discipline.
- Willingness for 20% domestic travel.
Nice to Have
- Prior experience supporting external audits or inspections as the design controls subject matter expert.
- ASQ CQE/CQA, ISO 13485 Lead Auditor, or related certifications.
Team & Environment
Design activities are distributed across EPD (software), operations, manufacturing engineering, product, and quality.
Benefits & Compensation
- Healthcare coverage.
- Dental coverage.
- Mental health support.
- Parental planning resources.
- Retirement savings options.
- Generous paid time off.
Dandy is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics.
