Senior Design Quality Engineer - Medical Devices

Katalyst CRO; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Philips is seeking a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards and quality requirements. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality in product design.

Responsibilities include design planning, reviews, V&V, design transfer to manufacturing, and rigorous risk management. The candidate will mentor teams to ensure alignment with quality standards and successful milestones.

Qualifications

• Knowledge of regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience identifying and supporting processes and design quality tools for tracking defects and design traceability.
• Exposure to design assurance/control in FDA-regulated medical devices.

Responsibilities

• Ensure compliance with Design Control throughout product lifecycle.
• Participate in design planning, reviews, and V&V activities.
• Review and approve design inputs/outputs and technical docs.
• Support DHF/DMR/DHR traceability creation and maintenance.
• Lead risk management throughout the product lifecycle including FMEA/hazard analysis.
• Oversee design transfer to manufacturing and process readiness.
• Drive CAPA initiation and root-cause analysis.
• Contribute to QMS process development and revisions.

Skills

Regulatory knowledge

Change management

Medical device design quality

Risk management tools

Education

Bachelor's degree (Medical Sciences / Healthcare Management / Industrial Engineering / Supply Chain)

Job description

Philips is seeking a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards and quality requirements. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality in product design.

Responsibilities include design planning, reviews, V&V, design transfer to manufacturing, and rigorous risk management. The candidate will mentor teams to ensure alignment with quality standards and successful milestones.