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Quality Engineer Principal II

Zimmer Biomet -
Milwaukee, WI

Job Details

Full-time
7 days ago

Benefits

Wellness program

Qualifications

Robot troubleshooting
Bachelor's degree in mechanical engineering
Electrical compliance testing
Robot integration
Systems integration
Sensor calibration
Quality records maintenance
Defect resolution root cause analysis
Machine vision systems
Electro-mechanical components
Accreditation standards (regulatory compliance area)
Software troubleshooting
Bachelor's degree in electrical engineering
Quality control product testing
Medical device testing
Technical documentation
ISO standards
Preventive action implementation
Safety regulations
Engineering
Equipment installation
Bachelor's degree in biomedical engineering
Mechanical Engineering
Production deviation management
Robotics engineering
Six Sigma methodology implementation
Biomedical Engineering
Quality control preventive actions
Corrective and preventive actions (CAPA)
Software installation

Full Job Description

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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging.

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)

EOE

What You Can Expect

How You'll Create Impact

What Makes You Stand Out

Applicable Regulatory & Consensus Standards

Your Background

Travel Expectations

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