Field Service Engineer-Surgical Robotics

Fusion Life Sciences Technologies LLC; Texas; On-site; USD 90,000 - 130,000; Full time

Job summary

Fusion Life Sciences Technologies LLC is seeking an engineer focused on serviceability in surgical robotics. You will define DfS requirements, design service-friendly architectures, and collaborate with robotics engineers to ensure maintainability and reliability in clinical settings.

The role involves performing FMEAs, developing maintenance protocols, and aligning with FDA 21 CFR Part 820, ISO 13485, and IEC standards to support safe, compliant product launches.

Qualifications

• Familiarity with FDA regulations, ISO 13485, and IEC standards.
• Technical writing skills for service manuals.
• Project management experience.
• Ability to communicate technically with team members.

Responsibilities

• Design for Serviceability (DfS) in surgical robotics and define DfS requirements for modular assemblies and sterile fields.
• Collaborate with robotics engineers to create service-friendly architectures and diagnostics.
• Conduct serviceability FMEAs and validate lifecycle and maintenance protocols.
• Develop service BOMs, preventive maintenance, calibration protocols, and built-in diagnostics.

Skills

FDA regulations

ISO 13485

Technical writing

Project management

Technical communication

Lean Six Sigma

Job description

Job Description

• Design for Serviceability (DfS) in Surgical Robotics
• Define and enforce DfS requirements for robotic systems: modular assemblies, quick-connect cabling, sterile field considerations, and tool-free access for critical components.
• Collaborate with robotics engineers to design service-friendly architectures (e.g., swappable joint modules, sensor calibration ports, embedded diagnostics).
• Conduct serviceability FMEAs and validate service life cycle.
• Develop service BOMs, preventive maintenance schedules, and calibration protocols aligned with orthopedic surgical use cases.
• Specify and validate built-in diagnostics, and telemetry.
• Support and execute segments of complex product development to advance projects through the design /development/V&V/launch process.
• Plan and execute verification protocols.
• Field Service Workflow
• Design service workflows that minimize disruption.
• Service readiness for new robotic platforms prior to commercial launch.
• Collaborate with engineering in defining installation, maintenance and troubleshooting procedures for robotic arms, navigation systems, and imaging integrations.
• Develop digital troubleshooting guides, assisted repair flows, and remote support capabilities for urgent intraoperative issues.
• Customer Experience
• Capture Voice of Field Service Engineer and support agents to inform service design—prioritizing speed, clarity, and confidence.
• Collaborate with Training to create competency-based learning paths for technicians servicing robotic systems in OR environments.
• Regulatory, Reliability & Compliance
• Ensure all service processes meet FDA 21 CFR Part 820, ISO 13485, and IEC 60601 standards for medical electrical equipment.
• Support post-market surveillance and feed reliability insights into product and service roadmaps.

Qualifications Required

• Familiarity with FDA regulations, ISO 13485, and IEC standards.
• Technical writing skills for service manuals.
• Project management experience.
• Ability to communicate technically with team members.

Preferred

• Experience with DfS, DHF, and FMEA.
• Lean Six Sigma or equivalent continuous improvement certification.
• Knowledge of industry practices. Practical knowledge related to the products/components that the position will support, e.g., electromechanical product components and assembly processes.
• Experience in process development.
• Experience in continuous improvement culture, skill sets, and tools to enhance quality and operational excellence.
• Experience with the proper use of common inspection tools, test equipment, and visual standards.

Core Competencies

• Systems Thinking & Cross-Functional Collaboration