Design Quality Engineer - Medical Device

Hiring: Design Quality Engineer - Medical Device

Location: Bothell, WA

Employment Type: W2 Contract

Rate: $40 $42/hr on W2

Experience: 5+ Years

Position Overview:

We are seeking an experienced Design Quality Engineer to support product design, development, risk management, Design Controls, verification and validation, and quality system activities within the medical device industry.

The ideal candidate will have strong experience in FDA-regulated medical device environments, Design Assurance, Design Controls, Risk Management, Design Verification and Validation, change management, and cross-functional collaboration within a regulated environment.

Key Responsibilities:

• Ensure compliance with Design Control and regulatory requirements throughout the product lifecycle.
• Participate in design planning, design reviews, and Design Verification & Validation (V&V) activities.
• Review design inputs, outputs, technical documentation, and design changes.
• Maintain design traceability documentation, including DHF, DMR, and DHR.
• Support design transfer to manufacturing and ensure process readiness.
• Lead and support Risk Management activities, including FMEA and hazard analysis.
• Ensure risk controls are implemented, verified, and properly documented.
• Support CAPA, root cause analysis, and corrective action activities.
• Support quality audits, inspections, and QMS compliance.
• Collaborate with cross-functional teams to resolve quality and design-related issues.

Required / Preferred Qualifications:

• Bachelor's degree in a relevant technical or healthcare-related field preferred.
• 5+ years of experience in an FDA-regulated medical device environment.
• Strong experience in Design Assurance, Design Controls, and Design Verification & Validation (V&V).
• Knowledge of FDA regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience in Risk Management, including FMEA and hazard analysis.
• Experience with change management, design transfer, and ECR/ECO processes.
• Knowledge of DHF, DMR, DHR, design traceability, CAPA, QMS, and audit support.
• Strong problem-solving, communication, and cross-functional collaboration skills.