About the Job:
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.
Candidates should have experience in one or more of the following:
- Heart CT imaging
- Heart real time fluoroscopy.
- Registration of the two modalities
- Working with AI for segmentation and detection
- Understanding 3D to 2D geometrical consideration
Responsibilities:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
- Background in software development, image registration and AI
- 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.
Additional Job Application Terms
This job is part of LinkedIn’s Full-Service Hiring beta program. Eligibility is limited to candidates located in and performing services in the United States, excluding those based in Alaska, Hawaii, Nevada, South Carolina, or West Virginia.
We’re committed to making our hiring process as smooth and timely as possible, and we understand that waiting to hear back can add to the anticipation. If you’re a potential fit, our team will reach out within two weeks to progress you to the next stage. If you don’t hear from us in that time, we encourage you to explore other opportunities with our team in the future, and we wish you the very best in your job search.