What You Can Expect
In this role, you will serve as a Senior Quality Engineer I supporting 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
- 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
- Collaborate with Manufacturing, R&D, Software, and Supplier Quality teams to resolve issues and drive product readiness
- Author and maintain quality documentation, test procedures, calibration records, and device history records (DHRs)
- Support nonconformance investigations, root cause analysis, and CAPA activities
- Ensure contract manufacturer adherence to ZB quality requirements, QSR, and ISO 13485 standards
- 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 3 years of relevant experience
- Bachelor's degree in Mechanical, Electrical or Biomedical Engineering preferred
- 3+ 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)
