Senior Technical Project Manager
Core
Leading complex engineering, manufacturing, and process development projects to support capacity expansion and new product introductions across a global medical device manufacturing network.
Role type
Senior Technical Project Manager (Manufacturing/Engineering)
Builds
New production equipment, manufacturing capacity, and compliant production processes for Infusion Care products.
Domain
Medical Devices / Manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management in manufacturing, cross-functional stakeholder leadership, regulated industry experience (Medical Devices/Pharma), process validation, FAT/SAT execution, CapEX budget handling, User Requirement Specifications (URS) development, regulatory compliance (FDA QSR/GMP/ISO 13485).
Preferred skills
Plastics production technologies, 3D CAD, global multi-site project management, formal project management certification (PMP/Prince2).
Technologies
3D CAD, FDA QSR, GMP, ISO 13485
Responsibilities
Manage projects from concept to implementation ensuring on-time, on-budget delivery; conduct process validation and FAT/SAT runs; ensure regulatory compliance for process changes; run 0-series production; develop process equipment for new products and capacity increases; present project status to Steering Groups; manage investment plans and applications.
Seniority
Senior, hands-on IC