Quality Sr Engineer I - Robotics Manufacturing & System Integration

About the role

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)

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)

Requirements

• Minimum 3 years of relevant experience in Quality Engineering or Manufacturing Engineering in medical devices or regulated industries
• Bachelor's Degree in Engineering preferred, with a focus on Mechanical, Electrical, or Biomedical Engineering
• Experience with robotic systems, software-controlled devices, or capital equipment
• Experience working with contract manufacturers and supplier environments

Qualifications

• Strong hands-on experience with robotic systems, electromechanical assemblies, or imaging systems
• Experience with system integration, calibration processes, and software-hardware interfaces
• 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

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
• 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)

Benefits

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

Pay

TBD

Schedule

Onsite, 5 days per week in Milwaukee, WI