Program Manager, Radiation Oncology Product Development
Location: Boca Raton, FL
Department: Research & Development
Reports to: Director, Software & Products
Job Description:
We are seeking a high-caliber Program Manager to lead the end-to-end lifecycle of complex medical device programs from initial concept through global commercialization. In 2026, our focus is on delivering “intelligence-powered” therapeutic devices that integrate seamlessly into hybrid care models. You will be responsible for orchestrating cross-functional teams (R&D, Quality, Regulatory, Manufacturing, and Marketing) to ensure that our clinical, business, and regulatory objectives are met within rigorous timelines and budgets.
Key Responsibilities:
- Strategic Leadership: Drive the execution of large-scale, multi-year product development cycles, including electromechanical hardware and SaMD (Software as a Medical Device) components.
- Compliance & Quality: Ensure all program activities comply with FDA 21 CFR Part 820, ISO 13485, and IEC 62304 (for software-heavy systems). Lead teams through successful phase-gate reviews and design control activities.
- Risk & Issue Management: Proactively identify technical, regulatory, and supply chain risks. Develop and execute contingency plans to mitigate roadblocks during development.
- Cross-Functional Coordination: Align internal and external resources, acting as the primary point of communication between technical teams and executive leadership.
- Budget & Resource Management: Manage program budgets (typically $5M–$15M+) and oversee the efficient allocation of engineering, clinical, and manufacturing resources.
- Market Launch Execution: Coordinate the transfer of products to manufacturing, ensuring training and post-market surveillance plans are established for a seamless launch.
Required Qualifications:
- Education: Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related technical field.
- Experience: 6+ years of professional experience, with at least 3–5 years specifically leading complex medical device programs.
- Technical Expertise: Proven experience with radiation oncology (or similar) medical devices, AI-integration in clinical environments, or digital twin modeling is highly desirable for 2026 applicants.
- Certifications: PMP (Project Management Professional) or PgMP is required. Familiarity with Agile/Scrum for software development in regulated environments is a major plus.
- Regulatory Mastery: Deep understanding of global regulatory submission pathways (PMA, 510(k), NMPA, EU MDR) and risk management standards (ISO 14971).
Core Competencies:
- Influence Without Authority: Ability to lead and guide cross-functional colleagues who are not direct reports.
- Strategic Vision: Capacity to manage minute technical details while simultaneously maintaining focus on the “big picture” business strategy.
- Effective Communication: Exceptional written and oral communication skills for presenting status and strategic recommendations to stakeholders.
- Modern Tool Proficiency: Expert-level skill in Microsoft Project, Smartsheet, Asana, or Jira for real-time tracking.
Preferred Qualifications:
- Experience with Generative AI or Machine Learning applications in medical device functionality or documentation automation.
- Background in human factors engineering or cybersecurity for connected medical systems.
- Six Sigma DFSS