Dandy

Design Control Engineer

Dandy

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $101,150 - $119,000 per year

About the role

  • 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

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
Benefits
  • healthcare
  • dental
  • mental health support
  • parental planning resources
  • retirement savings options
  • generous paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
design controlsverification and validation (V&V)risk managementISO 13485FDA 21 CFR 820ISO 14971IEC 62304design change impact assessmentdocument controldesign transfer
Soft Skills
cross-functional leadershiptechnical writingcommunicationorganizational skillsproblem-solvingcollaborationpresentation skillsattention to detaildecision-makingadaptability