• Quality Principal Engineer II

    Zimmer Biomet (Austin, TX)


    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

     

    As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on 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 environment where every team member feels included, respected, empowered and recognised.

     

    What You Can Expect

     

    The Principal Quality Engineer provides technical leadership 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 Principal QE 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. Mentors junior staff within the department and may direct their workload

    How You'll Create Impact

    + Serve as the design assurance lead for assigned robotic system programs, ensuring design control deliverables comply with 21 CFR 820.30, ISO 13485, and internal procedures.

    + Lead 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

    + 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

    Required:

    + Bachelor's Degree in Engineering and 8 years of relevant experience or equivalent experience

    Preferred:

    + Bachelor’s degree in Mechanical, Electrical, Systems, Biomedical, or Robotic Engineering.

    + 8+ years of experience in medical device engineering, including 6+ years in design assurance or development quality.

    + Experience with robotic or complex electromechanical medical systems.

    + Certification such as ASQ CQE or CQA desirable.

     

    Travel Expectations

     

    Up to 20%

     

    EOE/M/F/Vet/Disability