ZYSTRON STRUT

Company
Zimmer Biomet Spine (now Highridge Medical)

Timeframe
2017

Role
Senior Quality Engineer II, Product Design

Project Goal
Develop a titanium 3D-printed interbody cage for spine fusion surgeries, capitalizing on the unique geometries possible with additive manufacturing.

Risk Analysis

Led risk assessment in accordance with ISO 14971.

Design Control

Managed design control strategies for 3D printing files, introducing new documentation and design control processes.

GD&T Application

Ensured complex geometries were correctly dimensioned and toleranced, compatible with existing inspection equipment.

Process Validation

Conducted operational and performance qualification for ultrasonic cleaning, ensuring compliance with stringent standards.

Sterilization

Set up dose audit procedures for gamma sterilization, ensuring ISO 11137 compliance.

OUTCOME

Successfully managed the introduction of 3D printing in medical device design, enhancing Zimmer Biomet Spine's product offerings and meeting rigorous quality and safety standards.