Job Title: Design Quality Engineer
Location: Bothell, WA
Employment Type: W2 Contract
Pay/Rate Range: $37 $41/hr on W2
Industry: Medical Device
Experience Required: 5+ years
Job Description
We are seeking an experienced Design Quality Engineer (DQE) to support medical device product design and development activities. This position partners closely with R&D, Regulatory, Manufacturing, Quality, and Supplier teams to ensure quality and regulatory requirements are incorporated throughout the product lifecycle.
Key Responsibilities
- Ensure compliance with Design Control requirements in accordance with 21 CFR Part 820 and ISO 13485.
- Participate in design planning, cross-functional design reviews, and Design Verification & Validation (V&V) activities.
- Review and approve design inputs, design outputs, specifications, verification/validation documentation, and other technical records.
- Support creation and maintenance of traceability documentation and DHF, DMR, and DHR records.
- Ensure Design V&V activities adequately demonstrate that established requirements have been met.
- Review and approve Engineering Change Requests/Orders (ECR/ECO) and ensure design changes follow established change-control processes.
- Evaluate critical design inputs related to usability, reliability, performance, manufacturability, and safety.
- Support design transfer to manufacturing and ensure appropriate manufacturing/process readiness.
- Build effective relationships with internal and external stakeholders and provide Design Quality guidance to cross-functional teams.
Risk Management
- Guide risk-management activities throughout the medical device product lifecycle.
- Facilitate DFMEA, PFMEA, hazard analysis, and risk assessments.
- Ensure identified risk controls are appropriately implemented, verified, traceable, and documented.
- Support risk-management activities in accordance with ISO 14971.
QMS / Compliance Support
- Support internal and external quality audits and regulatory inspections.
- Maintain accurate and inspection-ready quality documentation.
- Support CAPA, root-cause analysis, corrective actions, and effectiveness activities.
- Contribute to development, implementation, and revision of Quality Management System processes.
Required Skills
- Strong hands-on experience with Medical Device Design Controls and Design Assurance.
- Design Verification & Validation (V&V).
- Design Inputs/Outputs and Requirements Traceability.
- DHF, DMR, and DHR documentation.
- Design Reviews and action-item closure.
- DFMEA, PFMEA, Hazard Analysis, and ISO 14971 Risk Management.
- ECR/ECO and Change Control.
- Design Transfer and Manufacturing Transfer.
- CAPA and Root Cause Analysis.
- Audit and inspection readiness.
- Strong cross-functional experience working with R&D, Regulatory, Manufacturing, Quality, and Supplier teams.
Regulatory Knowledge
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- EU Medical Device Regulation (EU MDR)
- European Medical Device Directive
- Canadian Medical Device Regulations
Minimum Qualifications
- Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or an equivalent/relevant discipline.
- 5+ years of experience in FDA-regulated medical device environments, with a strong focus on Design Quality, Design Assurance, or Design Controls.
- Demonstrated experience with risk management, change management, and design/manufacturing transfer.