Design Quality Engineer I

Design Quality Engineer I supports product development and lifecycle management for orthopaedic implants and instrumentation at DePuy Synthes. The role applies technical expertise to ensure product performance, safety, and regulatory compliance across trauma, extremities, craniomaxillofacial, and animal health businesses.

Responsibilities

• Support product development and lifecycle management for Trauma and CMF business lines
• Lead product realization planning and conduct formal technical design reviews throughout development phases
• Apply statistical methods and design excellence tools to verification and validation activities
• Support risk management activities including design, clinical, and production risk assessments
• Qualify new parts and processes with suppliers and support manufacturing transfer activities

Requirements

• Bachelor's degree in Engineering or Technical Science
• Minimum 1 year experience in GMP or ISO regulated industry
• Proficiency with Microsoft Office Suite
• Fluent English language skills
• Blueprint literacy and GD&T knowledge preferred
• Working knowledge of QSR (21 CFR 820) and ISO standards (13485, 14971) preferred
• Process and design excellence tools knowledge, certification a plus