What You Can Expect
In this role, you will serve as a Principal Quality Engineer II, leading contract manufacturing operations for surgical robotic systems. You will ensure the successful installation, calibration, validation, and final quality control of SiMD robotic cart systems and tracker stands at a contract manufacturer site in Milwaukee, WI.
You will work hands-on with complex electromechanical and software-integrated medical devices, ensuring all systems meet Zimmer Biomet specifications, regulatory requirements, and release criteria.
This position is onsite, 5 days per week in Milwaukee, WI.
How You'll Create Impact
- Lead onsite quality engineering activities for SiMD robotic cart and tracker stand systems at contract manufacturer facilities
- Oversee and execute clinical software installation and configuration on robotic carts and display systems
- Serve as the technical authority for system integration, calibration methodologies, and final release criteria for complex robotic medical devices
- Perform and/or validate robotic arm, camera (infrared tracker), and system-level calibrations
- Ensure completion and compliance of system integration verification and validation activities
- Execute and approve final QC testing, including:
- Electrical safety and functional testing
- Software/applicative system testing
- Hardware/system integration verification
- Lead cross-functional quality initiatives across Manufacturing, R&D, Software, Regulatory and Supplier Quality teams to ensure successful product launches, manufacturing scalability and sustained compliance
- Author and maintain quality documentation, test procedures, calibration records, and device history records (DHRs)
- Lead complex product and manufacturing quality investigations, driving enterprise-level CAPA strategies and systemic corrective actions to improve product reliability and regulatory compliance
- Ensure contract manufacturer adherence to ZB quality requirements, QSR, and ISO 13485 standards
- Establish best practices, standards and validation methodologies
- Provide technical guidance and training to manufacturing personnel
- Participate in internal/external audits (FDA, notified bodies, suppliers)
What Makes You Stand Out
- Strong hands-on experience with robotic systems, electromechanical assemblies, or imaging systems
- Experience with system integration, calibration processes, and software-hardware interfaces
- Ability to troubleshoot complex systems involving robotics, sensors, and software applications
- Strong knowledge of medical device regulations (FDA QSR, ISO 13485)
- Familiarity with electrical safety standards and system-level verification testing
- Knowledge of validation (IQ/OQ/PQ), calibration methods, and quality tools (FMEA, CAPA, DMAIC)
- Excellent problem-solving skills and ability to work independently in a manufacturing environment
- Effective communication and cross-functional collaboration skills
Applicable Regulatory & Consensus Standards
- Ensure compliance with FDA and EU MDR requirements by applying relevant recognized consensus standards for medical robotic systems and SiMD, including:
- Quality & Risk Management
- ISO 13485 - Medical Device Quality Management Systems
- ISO 14971 - Application of Risk Management to Medical Devices
- Software & SiMD
- IEC 62304 - Medical Device Software Lifecycle Processes
- FDA Guidance on Software as a Medical Device (SaMD) and cybersecurity
- IEC 82304-1 - Health software product safety
- Usability & Human Factors
- IEC 62366-1 - Usability Engineering
- Electrical & System Safety
- IEC 60601-1 - General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2 - Electromagnetic Compatibility
- IEC 60601-1-6 - Usability (aligned to IEC 62366)
- Robotics & Complex Electromechanical Systems
- ISO 10218-1 / 10218-2 - Safety Requirements for Industrial Robots (as applicable to collaborative systems)
- IEC 80601 (where applicable for medical electrical equipment systems)
- EU MDR Compliance
- Regulation (EU) 2017/745 (MDR) - General Safety and Performance Requirements (GSPR)
- MEDDEV & MDCG guidance (clinical evaluation, software qualification, cybersecurity)
Your Background
- Minimum Requirements: Bachelor's Degree in Engineering and 8 years of relevant experience or equivalent experience
- Bachelor's degree in Mechanical, Electrical or Biomedical Engineering preferred
- Advanced degree preferred
- 8+ years of experience in Quality Engineering or Manufacturing Engineering in medical devices or regulated industries preferred
- Experience with robotic systems, software-controlled devices, or capital equipment preferred
- Experience working with contract manufacturers and supplier environments preferred
Travel Expectations
Up to 25% travel (primarily between Zimmer Biomet sites and Milwaukee contract manufacturer)
