Sr Project Engineer (Onsite - Acton, MA)
Core
Lead supplier capital and tooling qualifications, manage prototype suppliers, and drive new product introductions for medical device components.
Role type
Senior Supplier Project Engineer
Builds
Prototype builds, precision tooling, and manufacturing equipment for medical devices
Domain
Medical devices / Supply chain engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier tooling project management, IQ/OQ/PQ protocol authoring, PFMEA, control plans, Measurement System Analysis, cross-functional team leadership, risk mitigation
Preferred skills
Six Sigma or Lean certification, PMI project management certification, experience in regulated medical device industry, direct material supplier background
Technologies
Smartsheet, Excel
Responsibilities
Lead supplier capital and tooling qualifications from kick-off to production, own project schedules and budgets, partner with R&D/Quality/Manufacturing for design-for-manufacturability, coordinate supplier validation protocols, manage equipment installation and start-up, evaluate prototype suppliers and manage deliveries, investigate quality issues and lead corrective actions
Seniority
Senior, hands-on IC