Systems Engineer : Surgical Robotics R&D

A pioneering endoluminal surgical robotics startup based in Boston is redefining what is possible inside the gastrointestinal tract. With a platform designed for both upper and lower GI procedures, this company is building the tools that will allow surgeons to operate with precision in anatomical spaces that have historically been inaccessible to robotics. The team is small, deeply technical, and moving fast toward first-in-human studies.

The Systems R&D Engineer will be a core contributor to the design, integration, and validation of the robotic platform, working across mechanical, electrical, and software domains to bring a complex, novel system from development to clinical reality.

This company is developing the next generation of endoluminal robotic platforms for minimally invasive surgery across the upper and lower gastrointestinal tract. Its technology is designed to expand the boundaries of what can be accomplished through natural orifice access, reducing the need for external incisions and enabling procedures that were previously difficult or impossible.

Backed by strategic investors and led by a team of experienced medtech and robotics veterans, the company is in active product development and preparing for its first clinical programs. This is an opportunity to join at a foundational stage and shape both the technology and the culture of a company with significant clinical and commercial potential.

The Systems R&D Engineer will own the integration of hardware, software, and control systems across the endoluminal robotic platform. This individual will work hands‑on with prototype systems, contribute to design verification and validation, and collaborate closely with mechanical, electrical, and software engineering teams as well as clinical advisors. The ideal candidate brings a systems‑level perspective to complex problem solving and thrives in the ambiguity of early‑stage product development.

• Lead systems‑level design and integration of the endoluminal robotic platform, ensuring hardware, firmware, and software components function reliably as a cohesive system
• Develop and execute system integration testing protocols, including bench testing, functional verification, and failure mode analysis
• Contribute to design history files, risk management documentation, and design controls in compliance with FDA 21 CFR Part 820 and ISO 13485 quality system requirements
• Collaborate with mechanical engineers on catheter‑based and flexible robotic mechanism design, including actuation, steering, and tool deployment systems
• Partner with electrical and firmware engineers to define interfaces, communication protocols, and embedded control architectures
• Support simulation and modeling efforts to validate system performance prior to physical build cycles
• Participate in cadaveric and bench‑top surgical studies, working directly with clinical advisors to evaluate system performance and iterate on design
• Contribute to IP generation and the documentation of novel technical approaches
• Support regulatory submissions by providing technical documentation and responding to FDA inquiries
• Help scale engineering processes and best practices as the team grows toward design freeze and clinical trials

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a closely related discipline
• 3 to 8 years of experience in medical device R&D, with meaningful exposure to complex electromechanical systems
• Demonstrated experience integrating hardware and software subsystems in a regulated medical device environment
• Familiarity with FDA design controls, risk management (ISO 14971), and quality system requirements
• Strong analytical and troubleshooting skills, with the ability to diagnose and resolve system‑level failures across domains
• Experience with CAD tools (Solid Works preferred), and comfort working closely with mechanical prototypes
• Ability to work in a fast‑paced, ambiguous startup environment with a high degree of ownership and self‑direction

• Experience with flexible or continuum robotics, catheter‑based systems, or endoscopic platforms
• Background in GI, colorectal, or upper GI surgical devices or clinical environments
• Exposure to embedded systems, servo control, or real‑time control architectures
• Experience supporting first‑in‑human or early feasibility clinical studies
• Prior startup experience with demonstrated ability to operate across engineering disciplines

• Systems thinking across hardware, software, and controls
• Hands‑on prototyping and bench testing
• Design verification and validation rigor
• Clear technical communication and documentation
• Cross‑functional collaboration in small teams
• Comfort with ambiguity and iterative development
• Risk management and regulatory awareness
• Clinical intuition and patient‑centered design thinking