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Director –Research & Development (R&D)

OptraSCAN, San Jose

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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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