Design Quality Engineer — Medical Devices & Compliance

Katalyst CRO; Lafayette (LA); On-site; USD 90,000 - 130,000; Full time

Job summary

Philips seeks a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. You will work with R&D, regulatory, manufacturing and suppliers to embed quality into product design.

The role emphasizes design control, risk management, V&V, and design transfer, with leadership in cross-functional teams to ensure milestones and regulatory alignment.

Qualifications

• Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, or equivalent.
• Knowledge of medical device regulations such as 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, Canadian MDR, etc.
• Minimum of 5+ years in FDA-regulated medical device environments with a focus on Design Assurance/Control, risk.
• Experience identifying and supporting processes and design quality tools for defect tracking and traceability.

Responsibilities

• Design Control: participate in design planning, reviews, and V&V activities.
• Review and approve design inputs/outputs and documentation; support change control (ECR/ECO).
• Lead risk management activities including FMEA and hazard analysis.
• Support QMS processes, audits, and CAPA with root-cause analysis.
• Collaborate with internal/external stakeholders to embed quality into product design and transfer to manufacturing.

Skills

Design Control

Risk Management

QMS

CAPA

Education

Bachelor's Degree in Medical Sciences or equivalent

Job description

Philips seeks a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. You will work with R&D, regulatory, manufacturing and suppliers to embed quality into product design.

The role emphasizes design control, risk management, V&V, and design transfer, with leadership in cross-functional teams to ensure milestones and regulatory alignment.