The Senior Quality Engineer I provides technical expertise in design assurance and system-level quality for Class II robotic medical devices. This role ensures compliance with FDA, ISO 13485, and ISO 14971 requirements throughout product development and design transfer. The Senior QE I partners with R&D, Systems, and Electrical/Mechanical Engineering teams to proactively manage product risk, verify design robustness, and ensure the 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 and differentiated capabilities to Zimmer Biomet's already broad suite of customer-centric technology solutions. By joining this team you will be taking part in cutting edge technology used to improve patient outcomes and relieve pain 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.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
- Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.
- 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 3 years of relevant experience or equivalent experience.
Preferred:- Bachelor's Degree in Mechanical, Electrical, Systems, Biomedical or Robotic Engineering.
- 3+ years of experience in medical device engineering, including design assurance or development quality.
- Experience with robotic or complex electromechanical systems.
- Certification such as ASQ, CQE or CQA desirable.
Travel Expectations
Up to 20%
Expected Compensation Range
$80,000 - $100,000 USD / Annual
