Product Design Quality Engineer

• 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.