Medical Device Quality Engineer

Position Summary:

We are looking for a Manufacturing Engineer to ensure the biological safety of orthopedic implants and surgical instruments. You will be the technical lead in deploying AI tools to evaluate complex medical devices and manufacturing flows (e.g., 3D-printed porous structures). Your mission is to use AI to predict material leaching, and ensure every implant meets the rigorous demands of long-term skeletal integration.

Key Responsibilities:

• 
  AI-Driven Bio-Analysis: Use AI to evaluate the biological safety of complex orthopedic surfaces, including Supplier Change Notices (SCN) and Process Manufacturing Material Lists (PMML).
• Material Biocompatibility: Oversee safety evaluations for the medical devices to ISO 10993-1.
• Predictive Additive Manufacturing Risks: Apply AI models to predict how variations in 3D printing (SLS/DMLS) parameterslike powder reuse or laser intensityimpact the biological risk profile of orthopedic implants.
• Automated Cleanroom Intelligence: Deploy AI-monitored environmental controls to prevent biological contamination during the assembly and packaging of medical devices.

• Education: Degree in Mechanical, Manufacturing, or Biomedical Engineering.
• Experience: 3+ years in orthopedic or robotics manufacturing.
• AI Competency: Experience using AI-based quality software or predictive analytics for high-volume manufacturing