Senior Project Manager
Core
Plan, coordinate, and complete R&D projects for human milk analysis technology products, ensuring compliance with medical device standards and supporting product registration.
Role type
Senior Project Manager (Medical Devices/R&D)
Builds
Human milk analysis technology products for neonatal care
Domain
Medical Devices / Biotechnology
Deliverable
product features
Required skills
Project planning and coordination, Risk analysis, ISO 13485 compliance, Product registration documentation, Cross-functional team leadership, Embedded product lifecycle management
Preferred skills
IVD-instrument development, Systems engineering, Embedded product testing
Technologies
ISO 13485, QMS
Responsibilities
Perform detailed project plans supporting scope, timeframe, and budget; Define and update design input and specifications; Procure and coordinate external consultants; Monitor and track project progress and report deviations; Oversee post-market lifecycle management; Participate in audits and inspections
Seniority
Senior, hands-on IC