Design Quality Engineer

Title: Systems Design Quality Engineer

Location: Hybrid

Duration: Bothell, WA

Pay Rate: $50-$57.00/hr on W2 (Contract without benefits)

Position Overview

We are seeking an experienced Systems Design Quality Engineer to drive design control rigor, product risk management, and process validation strategies across complex hardware, software, and systems projects. Working under minimal supervision, you will ensure end-to-end alignment with regulatory standards from initial design inputs through verification, validation, design transfer, and post-market surveillance.

This role serves as a vital bridge between R&D, manufacturing, and regulatory teams—leveraging statistical tools, root cause analysis (RCA), and design-for-quality (DFQ) methodologies to maximize product reliability and safety throughout the entire product lifecycle.

Key Responsibilities

• Design Control & Life Cycle Management: Direct the full design control lifecycle—from defining and validating critical design inputs (usability, safety, performance, reliability) to managing design verification, validation, and seamless production transfer.
• Process Validation & Statistical Strategies: Formulate and execute comprehensive process validation plans using statistical analysis tools to ensure new products transition smoothly into manufacturing while meeting strict regulatory benchmarks.
• Risk Management Governance: Lead cross-functional risk management efforts across the product lifecycle, ensuring hazards and risks are systematically identified, evaluated, and mitigated.
• Quality Documentation & Compliance: Draft and maintain critical quality engineering artifacts, including specialized hardware, software, and systems quality plans, technical files, and verification/validation protocols.
• Post-Market Surveillance & CAPA: Analyze post-market surveillance (PMS) performance data to identify field trends, initiate corrective/preventive actions (CAPAs), conduct root cause investigations, and feed actionable insights back into design and manufacturing.
• Continuous Improvement & Audit Readiness: Apply continuous improvement practices to maintain perpetual audit readiness, lead CAPA execution, and optimize overall design quality practices.
• Cross-Functional Mentorship: Guide internal and external stakeholders on design quality standards, defect management strategies, and compliance milestones.

Required Education & Experience

• Education: Bachelor’s or Master’s degree in Mechanical Engineering, Electronics Engineering, Biomedical Engineering, or a related scientific/technical field.
• Experience Thresholds:
• Bachelor’s Degree: Minimum 5+ years of professional experience in Quality Engineering, Safety Engineering, R&D Engineering, or a related domain.
• Master’s Degree: Advanced entry option available with relevant academic engineering focus.

Preferred Skills & Qualifications

• Certification: Six Sigma Green Belt or Black Belt preferred.
• Core Design Quality Competencies:
• Design for Quality (DFQ) & Design Quality Management
• Design Verification & Validation (V&V) Planning and Product Test Design
• Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA) methodologies
• ISO 13485 / FDA QSR / Regulatory Compliance Frameworks
• Product Reliability, Defect Management, & Data Interpretation
• Technical Documentation, Risk Assessment, and Audit Readiness