Director, Systems Engineering

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About the Company Activ Surgical is an early-stage medical device startup focused on transforming surgical advanced visualization through advanced imaging, computer vision, and AI. Our platform integrates cutting-edge technology to enhance laparoscopic and minimally invasive procedures. We’re seeking an experienced Director of Systems Engineering to lead our technical systems engineering group.
Position Summary As Director of Systems Engineering, you will lead a multi-disciplinary team integrating Activ Surgical technology with strategic partnerships and development programs, serving as the primary integration lead. In our fast-paced startup environment, you will combine leadership with direct technical contributions - overseeing and mentoring the team while actively participating in key systems engineering activities. Your scope will span imaging software, hardware integration, and overall systems engineering, balancing strategic direction with hands-on execution.
Key Responsibilities Leadership & Management Lead a high-performing multi-disciplinary R&D team spanning software, hardware, imaging, and systems engineering. Oversee resource planning, mentoring, and cross-functional execution. Foster a collaborative and fast-paced engineering culture.
Product Development System Architecture - Develop and lead system architecture design for integration of Activ Surgical technology into camera systems and robotics. Systems Engineering Lead - Own and execute systems engineering activities including requirements capture, traceability, and risk analysis. Verification – manage requirements verification for integrated product. Compliance - guide the design and testing  of Activ Surgical technology for satisfying regulatory and international compliance standards. Ensure technical readiness across all phases of development, from prototyping through manufacturing transfer and integration with strategic partners.
Regulatory & Quality Ensure compliance with regulatory and quality standards including ISO 13485, IEC 60601-1, IEC 62304, and FDA QSR. Oversee design control, verification/validation, risk management, and technical documentation. Serve as a key contributor to regulatory communications.
Requirements BS, MS, or PhD in Engineering, Computer Science, or a related field. 10+ years of experience in medical device R&D, with 5+ years in a management role. Strong background in medical device, imaging systems, computer vision, and/or real-time video. Systems engineering experience – requirements management, traceability, risk analysis, system architecture design Working knowledge of IEC 60601-1, IEC 62304, ISO 13485, and FDA QSR. Excellent team-building, communication, and project management skills.
Preferred: Knowledge of advanced imaging technologies (e.g. hyperspectral imaging, fluorescence imaging, multispectral imaging, or laser speckle contrast imaging). Experience with surgical vision systems, especially endoscopic or laparoscopic camera platforms. Exposure to manufacturing, system integration, and hardware bring-up. Exposure to agile software methods (e.g. JIRA experience for software development sprints and issue tracking). Benefits Fortune 500 Health & Wellness Benefits 401K Match Flexible PTO Paid Parental Leave
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Location:
Boston

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