Senior Design Quality Engineer – Medical Devices

Creative Solutions Services, LLC; Lafayette (LA); On-site; USD 90,000 - 130,000; Full time

Job summary

Philips is seeking a Design Quality Engineer to ensure product designs meet regulatory, quality, and customer requirements. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality into design and transfer to manufacturing.

Responsibilities include design planning, design reviews, verification/validation, and maintenance of design documentation, DHF/DMR/DHR, and risk controls throughout the lifecycle.

Qualifications

• Bachelor's degree in a medical sciences, healthcare management, industrial engineering, supply chain, or equivalent.
• Knowledge of medical device regulations and standards (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR).
• Experience in FDA-regulated medical devices with focus on design assurance and risk.

Responsibilities

• Ensure compliance with Design Control requirements throughout product lifecycle (21 CFR Part 820 / ISO 13485).
• Participate in design planning, reviews, verification and validation activities, and ensure action-item closure.
• Review and approve design inputs/outputs and critical documentation; support DHF/DMR/DHR maintenance.
• Guide risk management activities; facilitate FMEA and hazard analysis; implement risk controls.

Skills

Regulatory knowledge

Design Quality engineering

Risk management

FMEA

Education

Bachelor's Degree in Medical Sciences or related

Job description

Philips is seeking a Design Quality Engineer to ensure product designs meet regulatory, quality, and customer requirements. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality into design and transfer to manufacturing.

Responsibilities include design planning, design reviews, verification/validation, and maintenance of design documentation, DHF/DMR/DHR, and risk controls throughout the lifecycle.