Senior Engineer, GPE Lifecycle Management

About the role

Join Stryker’s Global Product Engineering team to support the Trauma & Extremities portfolio, overseeing design specifications for over 50,000 articles including bone plates, screws, and external fixators.

Key responsibilities

• Maintain compliance with FDA, EU MDR, ISO 13485 and internal standards through design change management and regulatory support.
• Lead continuous improvement projects, create project plans, assign work packages, and drive CAPA activities.
• Collaborate with Regulatory Affairs, Technical Publications, Design Quality, and Marketing to address design questions for international registrations.
• Drive value improvement, design optimization, and cost‑effectiveness initiatives.

Required profile

• Bachelor’s or master’s degree in mechanical engineering, biomedical engineering or related field.
• 4‑7 years of engineering experience, including 2+ years in the medical device industry.
• Experience with NC/CAPA, ECN/ECR processes and sustaining engineering activities.

Required skills

• Proficiency with CAD and PLM systems.
• Experience using Creo and Windchill.
• Knowledge of FEA tools such as Ansys.
• Understanding of materials, manufacturing processes, and risk‑based decision making.