Senior Design Quality Engineer - Medical Devices

Fives DyAG Corp.; San Diego (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

Philips is hiring a Design Quality Engineer to ensure products are designed and developed compliant with regulatory standards, quality requirements, and customer expectations. This role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Responsibilities include leading design controls, design reviews, and risk management across the product lifecycle, with emphasis on V&V, traceability, and change control to meet regulatory needs.

Qualifications

• Bachelor’s degree in medical sciences, healthcare management, industrial engineering, supply chain management or equivalent.
• Knowledge of medical device regulations, requirements, and standards (21 CFR Part 820, ISO 13485, ISO 14971, EU MDR/EC directives).
• Change Management (design and manufacturing transfer).
• Minimum of 5+ years in FDA-regulated medical device environments focusing on design assurance/control and risk.
• Experience using design quality tools for tracking defects, design traceability, and reliability-focused design.

Responsibilities

• Ensure compliance with Design Control throughout the product lifecycle.
• Participate in design planning, design reviews, and design verification/validation activities.
• Review and approve design inputs, outputs, and technical documentation.
• Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
• Ensure Design Verification & Validation activities meet requirements.
• Review and approve Engineering Change requests/orders and ensure proper change control.

Skills

Design Control

Risk Management

Change Management

Quality Assurance

Regulatory Knowledge

Cross-functional Collaboration

Education

Bachelor's degree

Tools

FMEA

Job description

Philips is hiring a Design Quality Engineer to ensure products are designed and developed compliant with regulatory standards, quality requirements, and customer expectations. This role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Responsibilities include leading design controls, design reviews, and risk management across the product lifecycle, with emphasis on V&V, traceability, and change control to meet regulatory needs.