Quality Assurance Engineer

NuWest Group; Bellevue (WA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) matching

PTO

Job summary

NuWest Group is seeking a Design Assurance / Quality Assurance Engineer in Bellevue, WA, to bridge engineering execution and regulatory compliance. You will embed with the product development team, ensuring DHF readiness for 510(k) submissions and compliance with ISO 13485, 21 CFR 820, and related standards.

This R&D-focused role concentrates on design controls, risk management, software/ usability QA, and regulatory submissions rather than manufacturing-floor quality.

Qualifications

• Bachelor's degree in Engineering; master's degree preferred.
• 5+ years of design assurance or quality engineering experience in medical device development.
• Hands-on knowledge of ISO 14971, IEC 62304, IEC 62366, and IEC 60601-1.

Responsibilities

• Lead design control activities (inputs, outputs, design reviews, verification, validation, design transfer) under 21 CFR 820 and ISO 13485.
• Facilitate and maintain risk management files (FMEA, FTA, hazard analyses) across hardware and software programs per ISO 14971.
• Guide software teams on IEC 62304 compliance and support IEC 62366 usability workflows.
• Provide quality oversight for hardware activities related to IEC 60601-1 and coordinate testing with external labs.
• Compile data for 510(k) or regulatory submissions and support documentation packages.
• Maintain SOPs/templates and support internal/external audits.

Skills

Design Controls

Regulatory Knowledge

Risk Management

Software Quality

Electrical Safety

QMS Compliance

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

21 CFR 820

ISO 13485

IEC 62304

IEC 60601-1

Job description

Design Assurance / Quality Assurance Engineer

Location: Bellevue, WA

Job Type: Full-Time, Permanent

Schedule: Monday - Friday, 8:00 AM - 5:00 PM

Work Model: On-site with hybrid flexibility (up to 2 days remote per week, based on project needs)

Travel: 5% - 15% (External test labs, contract manufacturers, regulatory consultants)

Role Overview

We are seeking a detail-oriented Design Assurance / Quality Assurance Engineer to serve as the quality and regulatory standards expert within our R&D organization. In this role, you will be embedded directly within the product development team, providing hands-on guidance to hardware engineers, firmware developers, and software engineers. Your primary focus will be bridging the gap between engineering execution and regulatory compliance to ensure Design History File (DHF) documentation is structured for 510(k) submissions.

Note: This is an R&D-focused product development role, not a manufacturing-floor quality position.

Key Responsibilities

• Design Controls: Lead and facilitate design control activities (inputs, outputs, design reviews, verification, validation, and design transfer) under 21 CFR 820 and ISO 13485 to ensure deliverables are traceable and audit-ready.
• Risk Management: Facilitate and maintain risk management files (FMEA, FTA, hazard analyses) across hardware and software product programs in accordance with ISO 14971.
• Software & Usability Quality: Guide software teams on IEC 62304 compliance (including SaMD frameworks and SOUP risk analysis) and support human factors/usability workflows under IEC 62366.
• Electrical Safety & Performance: Provide quality oversight for hardware activities related to the IEC 60601 series, coordinate testing with external laboratories, and support resolution of non-conformities.
• FDA Submissions: Compile performance data summaries, standards compliance matrices, and technical documentation packages to support 510(k) or Letter to File submissions.
• QMS Integration: Maintain compliance with ISO 13485 requirements, author SOPs/templates, and support internal/external audit activities.

Qualifications & Requirements

• Education: Bachelor's degree in Engineering (Biomedical, Electrical, Mechanical, Software, or related field); Master's degree preferred.
• Experience: 5+ years of design assurance or quality engineering experience in medical device product development.
• Standards Mastery: Hands-on working knowledge of ISO 14971, IEC 62304, IEC 62366, and IEC 60601-1.

Preferred Assets

• Experience with cardiac monitoring, ECG/EKG devices, patient-worn wearables, or Class II active medical devices.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC).
• Familiarity with cloud-based platforms (SaaS/SaMD), cybersecurity guidance (IEC 81001-5-1), or AI/ML-based medical device frameworks.
• Comprehensive Medical, Dental, and Vision insurance
• 401(k) matching program
• Paid Time Off (PTO)
• Professional development support (standards training and certification reimbursement)