Sr. Systems R&D Engineer

3 weeks ago

Boston, United States The Mullings Group Full time

Sr. Systems R&D Engineer : 1st Gen Endoluminal Robotics Build Our client is a Boston-based surgical robotics start-up pioneering next-generation endoluminal robotic platforms designed to expand the frontiers of minimally invasive surgery. Our multidisciplinary team integrates advanced robotics, precision mechatronics, and intelligent sensing to deliver transformative clinical outcomes and improve patient care. Key Responsibilities Define and manage system-level design requirements spanning circuitry, firmware, and control software for endoluminal robotic subsystems. Collaborate with electrical, software, and mechanical engineers to ensure cross-disciplinary integration and compliance with design inputs. Develop and implement test methods and fixtures for subsystem and full-system evaluation, including functional, safety, and reliability testing. Lead the creation and execution of V&V plans, protocols, and reports, ensuring traceability to design requirements and alignment with FDA design control standards. Conduct system-level debugging and root-cause analysis across electrical and software domains. Support risk management activities (FMEA, fault tree analysis) and contribute to design history documentation. Interface with clinical, manufacturing, and regulatory teams to ensure system designs meet user and compliance requirements. Qualifications B.S. or M.S. in Electrical Engineering, Computer Engineering, Systems Engineering, or related field. 5+ years of experience in medical device development, robotics, or complex mechatronic systems. Demonstrated expertise in embedded software integration, circuitry design, and test method development. Strong understanding of systems engineering principles, including requirements management and V&V under FDA 21 CFR 820.30 or ISO 13485 frameworks. Proficiency with tools such as Altium, MATLAB/Simulink, Python, or LabVIEW for design validation and data analysis. Preferred Experience with surgical robotics, endoluminal navigation, or imaging-guided systems. Familiarity with IEC 60601, ISO 62304, and ISO 14971 standards. Hands-on experience with system bring-up, bench testing, and prototype integration in a lab environment. Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Product Management Industries Medical Equipment Manufacturing, Robotics Engineering, and Biotechnology Research Boston, MA $120,000.00-$140,000.00 #J-18808-Ljbffr

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