Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
What You Can Expect
The Senior Quality Engineer II provides technical expertise in design assurance and system-level quality forClass II robotic medical devices. This role ensures compliance with FDA, ISO 13485, and ISO 14971 requirementsthroughout product development and design transfer. The Senior QE II partners with R&D, Systems, andElectrical/Mechanical Engineering teams to proactively manage product risk, verify design robustness, and ensurethe highest standards of safety, reliability, and performance. May mentor junior staff within the department.
Monogram's surgeon-guided semi- and fully autonomous robotic technologies are expected to add new anddifferentiated capabilities to Zimmer Biomet's already broad suite of customer-centric technology solutions. Byjoining this team you will be taking part in cutting edge technology used to improve patient outcomes and relievepain for patients across the globe. Excited to join us? Submit your application now.
This position is onsite, 5 days per week in Austin, Texas.
How You'll Create Impact
What Makes You Stand Out
Your Background
Minimum Requirements: Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience.
Preferred:
Travel Expectations
Up to 20%
EOE
What You Can Expect
The Senior Quality Engineer II provides technical expertise in design assurance and system-level quality forClass II robotic medical devices. This role ensures compliance with FDA, ISO 13485, and ISO 14971 requirementsthroughout product development and design transfer. The Senior QE II partners with R&D, Systems, andElectrical/Mechanical Engineering teams to proactively manage product risk, verify design robustness, and ensurethe highest standards of safety, reliability, and performance. May mentor junior staff within the department.
Monogram's surgeon-guided semi- and fully autonomous robotic technologies are expected to add new anddifferentiated capabilities to Zimmer Biomet's already broad suite of customer-centric technology solutions. Byjoining this team you will be taking part in cutting edge technology used to improve patient outcomes and relievepain for patients across the globe. Excited to join us? Submit your application now.
This position is onsite, 5 days per week in Austin, Texas.
How You'll Create Impact
- Support design assurance for assigned robotic system programs, ensuring design control deliverables comply with 21 CFR 820.30, ISO 13485, and internal procedures.
- Support the development and maintenance of 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.
- Participate in DFX (Design for Manufacturability, Reliability, Serviceability, and Testability) reviews and ensure that quality requirements are incorporated into design outputs.
- 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.
What Makes You Stand Out
- 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.
Your Background
Minimum Requirements: Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience.
Preferred:
- Bachelor's Degree in Mechanical, Electrical, Systems, Biomedical or Robotic Engineering.
- 5+ years of experience in medical device engineering, inluding design assurance or development quality.
- Experience with robotic or complex electromechanical systems.
- Certiciation such as ASQ, CQE or CQA desirable.
Travel Expectations
Up to 20%
EOE