Quality Sr Engineer II

About the role

The Senior Quality Engineer II at Zimmer Biomet supports the development and maintenance of risk management files, verifies design robustness, and ensures the highest standards of safety, reliability, and performance for robotic medical devices. This role collaborates with various departments to align design and production readiness, and mentors junior staff.

Responsibilities

• Support design assurance for assigned robotic system programs, ensuring compliance with FDA, ISO 13485, and internal procedures.
• Develop and maintain risk management files per ISO 14971, including system-level DFMEA, use-related risk analysis, and risk traceability to design mitigations.
• Review and approve design verification and validation plans, protocols, and reports to confirm product performance and regulatory compliance.
• Provide quality input during requirements definition, design reviews, and system integration phases to identify potential failure modes early.
• Ensure robust traceability between design inputs, risk controls, verification, and validation activities.
• Collaborate with Software Quality, Supplier Quality, and Manufacturing partners to ensure alignment across design and production readiness.
• Contribute to and continuously improve the Design Control and Risk Management procedures within the Quality Management System (QMS).
• Support internal and external audits, CAPA investigations, and regulatory submissions with design assurance documentation.
• Mentor and coach engineers in design assurance principles, quality engineering methods, and compliance practices.

Requirements

• Comprehensive knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.
• Strong expertise in design controls, risk management, and verification/validation activities for complex electromechanical or robotic systems.
• Working knowledge of software and electronics integration sufficient to collaborate effectively with Software and Systems Quality teams.
• Proficiency in FMEA, fault tree analysis, root cause investigation, and statistical analysis (SPC, capability, DOE).
• Demonstrated ability to influence R&D and cross-functional teams in adopting quality-by-design principles.
• Excellent written and verbal communication skills, with experience authoring and reviewing technical documentation for regulatory compliance.
• Experience supporting design transfer and cross-functional development environments.

Qualifications

• Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience.
• Minimum of 5+ years of experience in medical device engineering, including design assurance or development quality.
• Experience with robotic or complex electromechanical systems.

Skills

• Comprehensive knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.
• Strong expertise in design controls, risk management, and verification/validation activities for complex electromechanical or robotic systems.
• Working knowledge of software and electronics integration sufficient to collaborate effectively with Software and Systems Quality teams.
• Proficiency in FMEA, fault tree analysis, root cause investigation, and statistical analysis (SPC, capability, DOE).
• Demonstrated ability to influence R&D and cross-functional teams in adopting quality-by-design principles.
• Excellent written and verbal communication skills, with experience authoring and reviewing technical documentation for regulatory compliance.
• Experience supporting design transfer and cross-functional development environments.

Benefits

Zimmer Biomet offers a comprehensive benefits package including development opportunities, robust employee resource groups (ERGs), a flexible working environment, location-specific competitive total rewards, wellness incentives, and a culture of recognition and performance awards. We are committed to creating an inclusive environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging.

Pay

The pay range for this position is $80,000 - $120,000 annually, commensurate with experience.

Schedule

This position is full-time, 5 days per week, based in Austin, Texas.