Program Manager, R&D
Core
Lead cross-functional teams to execute New Product Development (NPD) programs for structural heart disease device solutions, ensuring predictable execution and regulatory compliance.
Role type
Senior Program Manager, R&D (Medical Devices)
Builds
New Product Development programs for structural heart disease devices
Domain
Healthcare / Medical Devices / Structural Heart
Deliverable
product features
Required skills
Cross-functional team leadership, New Product Development (NPD) program management, PMO process design and tooling, Regulatory compliance (FDA), Budget management, Strategic planning, Resource allocation, Test plan and SOP development
Preferred skills
Master's degree in technical/business field, PMP certification, People management experience, Enterprise/cross-division business unit experience
Technologies
PMO tools, QMS, EMS
Responsibilities
Lead moderately complex NPD programs; Design and deploy PMO solutions for predictable execution; Formulate and implement R&D policies and procedures; Provide leadership to design/development teams during transfer phase; Interface with internal/external resources (regulatory, customers) to meet requirements; Guide development of test plan protocols, SOPs, and specifications; Develop and maintain departmental budget; Contribute to business unit strategy planning; Review and approve project and quality system documentation; Manage organizational plans and resources; Support Quality Management Systems (QMS) and Environmental Management Systems (EMS) initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities