12/19/2025
Job Summary:
A Technical Program Director (TPD) in Medical Devices leads complex, cross-functional R&D programs from concept to commercialization, focusing on technical execution, quality (FDA/ISO 13485), risk management, and regulatory compliance, while managing budgets, timelines, and stakeholders to deliver innovative, safe, and effective devices. They bridge engineering, clinical, and business needs, ensuring seamless integration of hardware, software, and algorithms, and driving best practices in project management.
Duties and Responsibilities include, but are not limited to:
- Program Leadership: Provide technical and strategic direction for large programs, potentially involving hardware, software, AI, and clinical trials.
- Project Management: Oversee planning, scheduling, resource allocation, risk mitigation, and execution using methodologies like Agile, ensuring milestones are met.
- Quality & Regulatory Compliance: Ensure adherence to QMS (ISO 13485), design controls, and regulatory standards (FDA 21 CFR Part 820).
- Cross-Functional Collaboration: Partner with R&D, Clinical, Regulatory, Manufacturing, and Quality teams, resolving issues and driving integration.
- Stakeholder Management: Communicate progress, manage scope changes, and report to executive leadership.
- Technical Oversight: Lead root cause analysis, technical problem-solving, and integration of complex system-level components (hardware, software, firmware).
Knowledge, Skills, Abilities and Requirements:
- Education: BS in Engineering (Biomedical, Electrical, Mechanical) or related field.
- Experience: 10+ years in MedTech product development, with 5+ years in program/project management.
- Skills: Deep understanding of the full product lifecycle, risk management, Agile/Scrum, JIRA, ISO 13485, 21 CFR Part 820, and experience with medical device software/hardware.