Design Quality Engineer – Medical Devices Contract C2C Jobs

Tech Mirrors; Bothell (WA); On-site; USD 85,000 - 110,000; Full time

Job summary

Tech Mirrors is seeking a Design Quality Engineer in Bothell, WA, to ensure product quality in FDA-regulated medical devices. The candidate will support design control activities, risk management, and regulatory compliance throughout the product lifecycle.

The ideal candidate has over 5 years of experience, strong knowledge of design assurance processes, and familiarity with relevant regulations. Joining Tech Mirrors means engaging with cross-functional teams to enhance product quality.

Qualifications

• 5+ years of experience in FDA-regulated medical device environments.
• Strong knowledge of Design Control and Design Assurance processes.
• Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

• Support Design Control activities as per FDA and ISO standards.
• Participate in design reviews, verification, and validation activities.
• Drive Risk Management activities including FMEA and hazard analysis.

Skills

FDA-regulated environments

Design Control processes

Risk Management

Regulatory compliance

Education

Bachelor’s Degree in Medical Sciences or related field

Job description

Job Title: Design Quality Engineer - Medical Devices

Location: Bothell, WA

Work Mode: Onsite

Client: Tata Elxsi | Philips

Job Summary

We are looking for a Design Quality Engineer (DQE) with experience in medical devices and FDA-regulated environments. The role involves supporting product quality throughout the design and development lifecycle, ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Support Design Control activities as per FDA and ISO standards
• Participate in design reviews, verification, and validation activities
• Review design documents, technical files, and change requests (ECR/ECO)
• Maintain traceability documentation including DHF, DMR, and DHR
• Support design transfer activities to manufacturing
• Drive Risk Management activities including FMEA and hazard analysis
• Ensure implementation and documentation of risk controls
• Support CAPA activities, root cause analysis, and audit readiness
• Work closely with cross-functional teams including R&D, Manufacturing, and Regulatory

Required Skills & Experience

• 5+ years of experience in FDA-regulated medical device environments
• Strong knowledge of Design Control and Design Assurance processes
• Experience with Risk Management and Design for Reliability
• Familiarity with: 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other medical device regulations
• Experience with change management and manufacturing transfer

Education

Bachelor’s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field.