Overview

We are a fast-growing medical device company developing advanced Software as a Medical Device (SaMD) solutions for interventional cardiology and structural heart procedures. Our flagship technology integrates real-time fluoroscopy with pre-procedure 3D CT annotations to provide precise intra-procedural guidance, enhancing safety and clinical outcomes. Our innovation combines CT preprocessing, fluoroscopy preprocessing, AI-driven detection and tracking, anatomical landmark detection, and personalized DRR-based network training with cutting-edge registration protocols. We operate with a small, highly skilled in-house engineering team, supplemented by specialized contractors across several continents.

Summary: We are seeking a dynamic Director of Technology, Research & Development to lead a team of engineers in our start-up medical device company. This role involves overseeing the R&D pipeline, ensuring alignment with regulatory and market demands, and spearheading the development of groundbreaking technologies that enhance our company\'s growth and competitive advantage. The position is fully remote and reports directly to the Founder.

Responsibilities

• Strategic Leadership
  • Lead and manage a remote team of freelancers and employees in the R&D department.
  • Oversee the research and development pipeline, ensuring alignment with business goals and market needs.
  • Drive innovation in medical device technologies to maintain competitive advantage.
  • Collaborate closely with executive leadership, including product development, regulatory, and commercial teams, to ensure alignment across departments.
  • Ensure compliance with regulatory standards and guidelines.
  • Report regularly to the Founder on R&D progress, challenges, and opportunities.
• Research and Development Oversight
  • Oversee all stages of product research and early development, from ideation through feasibility and prototyping.
  • Manage the development of the user interface for procedural workflow integration.
  • Drive efficient design, testing, and validation of new devices in compliance with industry standards and regulations (e.g., FDA, ISO 13485).
  • Oversee data storage and management systems, ensuring compliance with healthcare data security regulations (e.g., HIPAA, GDPR).
  • Coordinate data engineering tasks, including structured pipelines for AI training datasets.
• Technology Innovation and Advancement
  • Develop and optimize AI-based detection and tracking algorithms, ensuring robustness in procedural conditions.
  • Promote a culture of innovation and scientific excellence within the organization.
  • Partner with external stakeholders (clinical sites) for collaborative innovation and research.
• Regulatory and Quality Collaboration
  • Ensure all research activities align with medical device regulations and quality system requirements.
  • Support regulatory strategy development by providing technical and scientific input.
• Talent and Organizational Development
  • Recruit, develop, and retain top engineers and technical talent.
  • Foster team collaboration, mentoring, and continuous professional development.

Ideal Candidate Profile

• Advanced degree (Ph.D. or Master\'s) in engineering, biomedical sciences, or a related field.
• 10+ years of leadership experience in R&D within the medical device or life sciences industry.
• Demonstrated success in bringing medical devices from concept through commercialization.
• Strong understanding of FDA regulations, ISO standards, and global medical device requirements.
• Visionary leader with excellent communication, strategic thinking, and stakeholder management skills.
• Ability to work and manage in a remote environment.

We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.