Principal Manufacturing Engineer
Core
Designing, testing, and implementing process improvements for manufacturing equipment to reduce cost, cycle time, and improve quality in medical device production.
Role type
Principal Manufacturing Engineer (Continuous Improvement & Change Management)
Builds
Manufacturing processes, production floor layouts, and capital projects for medical device components
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, budget management, process validation, root cause analysis, capital project oversight, equipment troubleshooting, vendor management, regulatory compliance (ISO 13485, GMP, OSHA), EH&S procedures
Preferred skills
Injection molding experience, Six Sigma, Lean Manufacturing, FDA regulations knowledge, mechanical/electro-mechanical/electrical/pneumatic/hydraulic technologies, PLCs, HMIs, vision systems, instrumentations
Technologies
PLCs, HMIs, vision systems, instrumentations, injection molding equipment
Responsibilities
Develop cost saving plans and project timelines, establish and manage project budgets, oversee development and installation of major capital projects, assist production areas on equipment and process problems, develop and execute process validations, perform daily check-ins on assigned production lines, coordinate new product or process start-ups, ensure compliance with statutory regulations and EH&S procedures
Seniority
Principal, hands-on IC with mentorship
