Senior Quality Engineer – Robotic Medical Devices

Zimmer Biomet; Austin (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

Zimmer Biomet in Austin, TX hires Senior Quality Engineer I to provide design assurance and system-level quality for Class II robotic medical devices. You will collaborate with R&D, Systems, and Electrical/Mechanical teams to manage risk and verify design robustness, ensuring safety, reliability, and regulatory compliance.

This onsite role offers opportunities to mentor others, contribute to design control and risk management procedures, and support audits and regulatory submissions.

Qualifications

• Bachelor’s Degree in Engineering and 3 years of relevant experience.
• Experience with robotic or complex electromechanical systems.
• Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 is preferred.

Responsibilities

• Provide design assurance for robotic system programs, ensuring compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
• Maintain risk management files per ISO 14971, including DFMEA, use-related risk analysis, and risk traceability.
• Review design verification and validation plans, protocols, and reports for performance and regulatory compliance.
• Mentor engineers on design assurance principles and QMS processes.

Skills

FDA QSR

ISO 13485

FMEA

DOE

SPC

Education

Bachelor’s Degree in Engineering

Tools

FMEA

SPC

DOE

Job description

Zimmer Biomet in Austin, TX hires Senior Quality Engineer I to provide design assurance and system-level quality for Class II robotic medical devices. You will collaborate with R&D, Systems, and Electrical/Mechanical teams to manage risk and verify design robustness, ensuring safety, reliability, and regulatory compliance.

This onsite role offers opportunities to mentor others, contribute to design control and risk management procedures, and support audits and regulatory submissions.