Design Quality Engineer

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

Job Description

The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

• Ensure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle
• Participate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items)
• Review and approve design inputs, outputs, and technical documentation.
• Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
• Review and approve, Engineering Change requests/Orders (ECR/ECOs).
• Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Design transfer to manufacturing, ensuring process readiness
• Guide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated
• Facilitate FMEA (Design and Process) and hazard analysis.
• Ensure risk controls are implemented, verified, and documented.
• Ensure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance
• Record, manage, and execute CAPA processes including root cause analysis and implementation of solutions
• Contributes to the development, implementation, and revision of QMS processes

Job Description

The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Roles & Responsibilities

• Ensure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle
• Participate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items)
• Review and approve design inputs, outputs, and technical documentation.
• Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
• Ensure Design Verification & Validation (V&V) activities meet requirements
• Review and approve, Engineering Change requests/Orders (ECR/ECOs).Ensure design changes follow proper change control processes.
• Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Design transfer to manufacturing, ensuring process readiness
• Guide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated
• Facilitate FMEA (Design and Process) and hazard analysis.
• Ensure risk controls are implemented, verified, and documented.
• Ensure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance
• Record, manage, and execute CAPA processes including root cause analysis and implementation of solutions
• Contributes to the development, implementation, and revision of QMS processes

Requirements

• Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc
• Change Management (Including design and Manufacturing transfer)
• Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.