Quality Sr Engineer I - Robotics Manufacturing & System Integration

Zimmer, Inc.•Milwaukee, WI

1d•Onsite

About The Position

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.

Requirements

Bachelor's Degree in Engineering
3 years of relevant experience
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
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, ISO 14971), Software & SiMD (IEC 62304, FDA Guidance on SaMD, IEC 82304-1), Usability & Human Factors (IEC 62366-1), Electrical & System Safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6), Robotics & Complex Electromechanical Systems (ISO 10218-1 / 10218-2, IEC 80601), EU MDR Compliance (Regulation (EU) 2017/745, MEDDEV & MDCG guidance)

Nice To Haves

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

Responsibilities

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)