Zimmer Biomet · 19 hours ago
Quality Engineer Sr II
Austin, TX
Full-time
Onsite
Senior Level
5+ years expZimmer Biomet is a global medical technology leader committed to enhancing patient mobility. The Senior Quality Engineer II role focuses on providing technical expertise in design assurance and quality for Class II robotic medical devices, ensuring compliance with regulatory requirements and collaborating with cross-functional teams to manage product risk and verify design robustness.
Health CareManufacturingMedical DeviceProduct Design
Responsibilities
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
Qualification
Required
Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience
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
Preferred
Bachelor's Degree in Mechanical, Electrical, Systems, Biomedical or Robotic Engineering
5+ 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
Benefits
Development opportunities
Robust employee resource groups (ERGs)
Flexible working environment
Location specific competitive total rewards
Wellness incentives
Culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
10001+ employees
H1B Sponsorship
Zimmer Biomet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Ivan Tornos
Chairman, President and CEO
D
David DeMartino
Senior Vice President, Investor Relations
Recent News
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2025-12-19
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