Principal Process Engineer - On-site
Core
Develops and optimizes manufacturing processes, equipment, and procedures for neurovascular medical devices to ensure quality, efficiency, and regulatory compliance.
Role type
Principal Process Engineer
Builds
Manufacturing processes and equipment for minimally invasive endovascular technologies (catheters, stent retrievers, flow diversion systems)
Domain
Medical device manufacturing / Neurovascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development and scale-up, Statistical process control (SPC), Equipment and material integration, Process validation strategy, Design for Manufacturing (DFM), Regulatory compliance (ISO 13485), Feasibility analysis, Tooling and fixture design
Preferred skills
Deep medical device experience (vascular/neurovascular), Cross-functional leadership, Advanced manufacturing methods (plastics/metals)
Technologies
None explicitly listed
Responsibilities
Provide technical and sustaining engineering support in manufacturing, Recommend and implement equipment/process modifications to improve yields, Integrate equipment and material capabilities to meet specifications, Review product development requirements for processing compatibility, Develop statistical analysis techniques and measurement systems, Lead innovation and optimization of new manufacturing concepts and procedures
Seniority
Principal, hands-on IC with strategic scope