Project Lead
Core
Manage technical qualification of Tier II component suppliers, lead supplier development, and resolve complex technical issues for custom part manufacturing.
Role type
Senior IC Project Lead (Manufacturing Engineering)
Builds
Custom medical device components via injection molding and tooling
Domain
Medical devices / Diabetes Care / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Injection molding process development, First Article Inspection (FAI) analysis, PpK data analysis, Design of Experiments (DOE), DMAIC methodologies, GMP compliance, Tool design qualification, Process optimization, Statistical analysis
Preferred skills
Polymer or Mechanical Engineering background, Master Molder level qualification, Tooling manufacturing site experience, Equipment design and specification, New material introduction (polymer pack material), Technical project management, Stamping/forming/packaging/adhesive knowledge
Technologies
Injection molding, Tooling, GMP, FDA, ISO
Responsibilities
Manage large scale complex multiple projects, Coordinate internal/external resources to achieve project goals, Provide technical leadership in process characterization and validation, Support suppliers in tool qualification and process optimization, Identify and document key process variables for Design Transfer, Optimize manufacturing processes for cost and quality improvements
Seniority
Senior, hands-on IC