Design Quality Engineer

Katalyst CRO; Denver (CO); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Design Quality Engineer (DQE) in Denver, Colorado. The DQE will ensure product compliance with regulatory standards and quality requirements. This role collaborates closely with R&D and manufacturing to embed quality in product design.

Candidates should possess a Bachelor's degree in a relevant field and have over 5 years' experience in FDA regulated environments, emphasizing design assurance and risk management.

Qualifications

• Bachelor's degree in Medical Sciences, Industrial Engineering, or related field.
• 5+ years of experience in FDA regulated medical device environments.
• Detailed knowledge of 21 CFR Parts 820 and ISO 13485.

Responsibilities

• Ensure compliance with Design Control requirements.
• Participate in design planning and design reviews.
• Manage and execute CAPA processes.

Skills

Knowledge of medical device regulations

Change Management experience

Design Assurance/Control

Risk Management

Detailed experience in design quality tools

Education

Bachelor's Degree in Medical Sciences or equivalent

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.

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.
• 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.
• Contribute 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.
• Experience with 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.
• 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.