Design Quality Engineer

Katalyst CRO; Bothell (WA); On-site; USD 75,000 - 95,000; Full time

Job summary

Katalyst CRO is seeking a Design Quality Engineer to ensure compliance with regulatory standards in product design development. This role involves participating in cross-functional design reviews and managing quality audits.

The ideal candidate will have at least 5 years' experience in FDA regulated environments and a Bachelor's degree in a relevant field. Strong knowledge of medical device regulations is essential.

Qualifications

• 5+ years' experience in FDA regulated medical device environments.
• Experience in identifying and promoting quality processes.
• Detailed knowledge of ISO 13485 and FDA regulations.

Responsibilities

• Ensure compliance with Design Control requirements.
• Participate in design planning and reviews.
• Facilitate FMEA and hazard analysis.

Skills

Knowledge of medical device regulations

Design Assurance/Control

Risk Management

Change Management

Education

Bachelor's degree in medical sciences or related field

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.

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 approval, 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
• Minimum required Experience:
• 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.
• Minimum required Education:
• Bachelor's degree in medical sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.