Design Quality Engineer

Katalyst CRO; Bothell (WA); On-site; USD 110,000 - 150,000; 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. You will work with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Responsibilities include design control, risk management, V&V activities, and design transfer to manufacturing, with a focus on ensuring traceability and adherence to FDA and ISO 13485 requirements.

Qualifications

• Experience in FDA regulated medical device environments is required.
• Proven ability to lead design quality activities across product life cycle.
• Knowledge of Design Control, risk management, and quality system processes.

Responsibilities

• Lead Design Control activities across product lifecycle.
• Participate in design planning, reviews, verification and validation.
• Ensure design inputs/outputs and documentation meet regulatory standards.
• Support traceability matrices and change control processes.
• Provide mentorship and align cross-functional teams with quality standards.
• Guide risk management and FMEA throughout development.
• Assist in design transfer to manufacturing and process readiness.
• Support audits, CAPA, and QMS processes.

Skills

Design Quality

Regulatory Compliance

Risk Management

Design Control

Change Management

Design Transfer

QMS

CAPA

FDA Regulations

ISO 13485

Education

Bachelor's Degree in Medical Sciences / Healthcare / Industrial Engineering or related

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.

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.

Responsibilities

Design Control:

• 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.

Risk Management Support:

• 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.

QMS Support (Audit, CAPA):

• 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.