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OptraSCAN

Director –Research & Development (R&D)

OptraSCAN, San Jose, California, United States, 95199

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About OptraSCAN

OptraSCAN is a global leader in

digital pathology

and

precision medicine

solutions, specializing in whole-slide imaging systems, AI-driven analytics, and cloud-enabled telepathology platforms. With customers across the US, Europe, and Asia, OptraSCAN is transforming disease diagnostics through cutting-edge technology and innovation. Role Overview

The

Director of R&D

will lead the innovation strategy, research programs, and next-generation product development across imaging hardware, AI/ML, optics, and software platforms. This role will guide cross-functional teams to bring high-performance digital pathology products from concept to commercialization, ensuring quality, scalability, and regulatory compliance. Key Responsibilities

Strategic Leadership Define and drive the R&D roadmap aligned with company vision and market needs. Identify emerging technologies (AI, optics, automation, cloud) for future product integration. Collaborate with executive leadership to shape long-term product strategy. Product & Technology Development Lead the design, development, and optimization of digital pathology scanners, imaging systems, and AI algorithms. Oversee feasibility studies, prototyping, and performance validation. Ensure integration of hardware, software, and cloud technologies into cohesive solutions. Guide research into optics, image processing, robotics, and high-resolution imaging systems. Team Leadership & Collaboration Manage and mentor cross-functional engineering teams (optical, mechanical, embedded, software, AI/ML). Foster a culture of innovation, collaboration, and accountability. Work closely with Clinical, Regulatory, and Quality teams to ensure product compliance and readiness for FDA/CE certifications. Project & Process Management Establish processes for efficient R&D execution, documentation, risk management, and product lifecycle management. Manage budgets, timelines, and resource allocation. Evaluate and manage external partnerships, vendors, and research institutions. Regulatory, Quality & Compliance Ensure R&D activities comply with ISO 13485, IEC standards, and FDA/CE requirements. Support regulatory submissions with technical documentation and data. Qualifications & Experience

Education Master’s or PhD in

Biomedical Engineering, Optics, Imaging Science, Electrical Engineering, Computer Science, or related fields . Experience 12 years of product development experience in medical devices, imaging systems, digital pathology, or diagnostics. Proven experience leading multidisciplinary R&D teams. Strong expertise in at least two of the following: Optical imaging / microscopy Image processing / AI–ML Embedded systems & hardware Cloud software & data platforms Robotics / motion systems Skills Strong technical leadership and ability to translate scientific concepts into commercial products. Deep understanding of product development lifecycle for regulated medical devices. Excellent communication and documentation skills. Strong problem-solving and decision-making abilities.

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