Design Quality Engineer

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.