Project Manager
Core
Provide technical leadership for design improvements and FDA compliance to sustain production of Class 1, 2, and 3 medical devices.
Role type
Senior Project Manager (Medical Device R&D)
Builds
Class 1, 2, and 3 medical devices
Domain
Medical Technology / Healthcare
Required skills
Project management, Risk management, FDA regulations knowledge, ISO standards knowledge, Design control management, Cross-functional coordination, Budget and schedule management, Stakeholder communication
Preferred skills
Manufacturing experience, PMP Certification
Technologies
Microsoft Project, Microsoft Office Suite
Responsibilities
Lead R&D projects through all phases and stage gates for commercialization, Manage project scope, schedule, and budget, Coordinate communication across multiple functions and facilities, Ensure projects meet launch goals and objectives, Act as communication link between project teams and senior management, Identify and manage project risk, Ensure Design Control requirements and Design History File compliance
Seniority
Senior, hands-on IC