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Operations Process Engineer - Surgical Robotics

Fusion Life Sciences Technologies LLC · Santa Clara, CA

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Title: Operations Process Engineer (Capital System) – Surgical Robotics (OTTAVA)Location: Santa Clara, CAWork Arrangement: 100% OnsiteExperience: 0–4 YearsJob OverviewSeeking an Operations Process Engineer to support the OTTAVA Surgical Robotic Platform. This role focuses on manufacturing execution, system integration, and technical troubleshooting within the capital system production line.The engineer will provide hands-on, shop-floor technical support for manufacturing test activities, robotic subsystem integration, and production troubleshooting. The successful candidate will collaborate with Manufacturing, Test Engineering, Quality, New Product Introduction (NPI) Engineering, and R&D teams to maintain production continuity, resolve technical issues, and ensure product quality and compliance.Key Responsibilities1. Manufacturing Test and System IntegrationSupport manufacturing operations, system integration, and testing activities for the OTTAVA surgical robotic platform.Provide first-line technical support to manufacturing associates and help resolve production issues.Collaborate with cross-functional engineering teams to address issues affecting product safety, quality, delivery, and production efficiency.Escalate technical issues when necessary to minimize production downtime.2. Troubleshooting and Root Cause AnalysisInvestigate manufacturing test failures using structured troubleshooting and problem-solving techniques.Troubleshoot hardware, software, electromechanical systems, and system interfaces.Analyze test results, identify root causes, and implement containment actions.Partner with Test Engineering, NPI Engineering, and Quality teams to develop and implement permanent corrective actions.Document recurring failures, troubleshooting procedures, and technical findings to improve manufacturing efficiency.3. Quality and ComplianceSupport quality system activities, including Change Controls, Corrective and Preventive Actions (CAPA), and Nonconformance Reports (NCRs).Participate in nonconformance investigations, root cause analysis, impact assessments, and corrective action implementation.Maintain accurate technical documentation and ensure compliance with approved procedures and applicable quality requirements.Support manufacturing processes in accordance with regulated industry standards and quality expectations.Required QualificationsBachelor’s degree in Engineering or a related technical discipline.0–4 years of relevant engineering experience; internships, co-ops, academic projects, research, and laboratory experience may be considered.Hands-on experience with engineering testing, system integration, scripting, or technical troubleshooting.Ability to interpret test results and troubleshoot hardware, software, and system-level failures.Basic scripting knowledge, preferably Python, including the ability to read and debug scripts.Strong analytical, problem-solving, technical documentation, and communication skills.Ability to collaborate effectively with Manufacturing, Test Engineering, Quality, NPI Engineering, and R&D teams.Ability to work 100% onsite in Santa Clara, CA.Preferred QualificationsExperience with Python, LabVIEW, MATLAB, automated test systems, data acquisition tools, SQL, or manufacturing data analysis.Experience troubleshooting electromechanical systems, robotics, complex capital equipment, or integrated hardware/software products.Exposure to regulated manufacturing environments, including medical devices, pharmaceuticals, biotechnology, aerospace, or automotive.Familiarity with Change Controls, CAPA, NCRs, root cause analysis, and corrective and preventive action processes.A hands-on, proactive approach to resolving production issues while maintaining quality, safety, and compliance.