Product Design Quality Engineer

Katalyst CRO; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Product Design Quality Engineer to support quality throughout the product development lifecycle in compliance with regulatory requirements and design control processes.

The role partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to ensure manufacturing readiness and effective risk control measures, including FMEA and CAPA investigations.

Qualifications

• Bachelor's degree in a technical discipline as listed in the posting.
• 5+ years in Design Quality/Design Assurance/Quality Engineering in FDA-regulated medical devices.
• Strong knowledge of Design Controls and product lifecycle management.
• Experience with V&V, design traceability, change management, and manufacturing transfer.

Responsibilities

• Support Design Control activities across product development per FDA and regulatory requirements.
• Participate in design planning reviews and V&V activities to meet quality objectives.
• Review and approve design documentation, inputs, outputs, specs, and records.
• Maintain Design History Files, DMRs, and related quality docs.
• Review ECRs/ECOs and changes to ensure proper change control.

Skills

Quality Engineering

Design Controls

Regulatory Knowledge

Cross-functional Collaboration

V&V

Education

Bachelor's degree in Engineering or related

Tools

QMS Software

CAPA System

Document Management System

Job description

Job Description The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities.

Responsibilities

• Support Design Control activities throughout the product development lifecycle in accordance with FDA and international regulatory requirements.
• Participate in design planning, cross-functional design reviews, and verification and validation (V&V) activities to ensure product quality objectives are achieved.
• Review and approve design documentation, including design inputs, outputs, specifications, and technical records.
• Maintain design traceability documentation, including Design History Files (DHF), Device Master Records (DMR), and related quality documentation.
• Review Engineering Change Requests (ECRs), Engineering Change Orders (ECOs), and design modifications to ensure compliance with established change control procedures.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality teams to support new product development and manufacturing readiness.
• Facilitate Design and Process FMEA activities, hazard analyses, and implementation of effective risk control measures.
• Support design transfer activities by ensuring manufacturing processes, documentation, and quality requirements are fully established prior to production.
• Participate in internal audits, quality system improvements, CAPA investigations, and continuous improvement initiatives.
• Contribute to Quality Management System (QMS) enhancements, documentation updates, and regulatory compliance efforts.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Healthcare Management, Industrial Engineering, or a related technical discipline.
• 5+ years of experience in Design Quality, Design Assurance, or Quality Engineering within an FDA-regulated medical device environment.
• Strong knowledge of Design Controls, Design Assurance principles, and product lifecycle management.
• Experience with Design Verification & Validation (V&V), design traceability, engineering change management, and manufacturing transfer.
• Working knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable international regulatory requirements.
• Experience supporting risk management activities, including Design FMEA, Process FMEA, hazard analysis, and risk mitigation.
• Familiarity with CAPA, internal audits, quality investigations, and Quality Management Systems (QMS).
• Excellent communication, documentation, analytical, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting new product development (NPD), design transfer, or manufacturing transfer projects.
• Knowledge of Design for Reliability (DfR), product traceability, and defect prevention methodologies.
• Experience working with global engineering, regulatory, and manufacturing teams.
• Background in respiratory care, patient monitoring, diagnostic imaging, or other medical device technologies is a plus.