Senior Engineer, GPE Lifecyle Management

Overview

Senior Engineer on the Global Product Engineering team, responsible for design specification, compliance, and continuous improvement for Stryker’s Trauma & Extremities products.

What you'll do

• Maintain and improve design specification and performance standards.
• Drive design change management and support regulatory submissions.
• Serve as a subject matter expert during internal and external audits.
• Apply design change processes, meet design requirements, and identify technical solutions.
• Oversee continuous improvement projects for existing products, including project planning and work package follow-up.
• Perform and sometimes lead cross-functional activities for design-related Non-Conformities and CAPA.
• Coordinate with Regulatory Affairs, Tech. Publications, Design Quality, and Marketing for international registrations and technical file creation for EU-MDR.

What you'll need

• 4-7 years of work experience.
• Experience in NC/CAPA and change management processes (ECN/ECR).
• Proficiency with CAD and a PLM system.
• Strong understanding of engineering fundamentals, product design, and risk-based decision making.
• Strong written and verbal communication skills.
• Bachelor’s or master’s degree in mechanical engineering or biomedical or related.
• Minimum 2+ years of medical device industry experience with exposure to sustaining engineering activities.

Nice to have

• Creo and Windchill knowledge highly desirable.
• Knowledge of FEA tools (e.g., Ansys), materials, and manufacturing processes.
• Experience managing product obsolescence projects for a large portfolio.

Details

• Work flexibility: Hybrid.
• Location: Gurugram, India.
• Travel percentage: None.