Principal Manufacturing Engineer
Core
Lead manufacturing scale-up, capacity expansion, and operational advancement for medical device manufacturing, steering major capital, equipment, and automation projects from concept through validation and rollout.
Role type
Principal Manufacturing Engineer (Regulated Medical Devices)
Builds
Production-scale manufacturing capabilities, automated equipment, and validated processes for in vitro diagnostics (IVD) and life science tools.
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing scale-up, CAPEX project management, Validation (IQ/OQ/PQ), Automation & controls integration, Cross-functional project leadership, Risk management, Technical documentation, Process improvement, Equipment qualification, Change control
Preferred skills
Experience in IVD, diagnostics, Pharma, or medical devices, Knowledge of FDA/ISO 13485/GMP regulations, Mentorship of junior engineers
Technologies
Automated equipment, Control systems, Validation protocols, Quality Management Systems
Responsibilities
Lead manufacturing scale-up and capacity increase projects, Manage full lifecycle CAPEX and automation projects, Provide technical leadership for validation activities, Lead resolution of complex manufacturing and quality issues, Support introduction of new products and technologies, Ensure alignment with IVD, ISO 13485, and GMP standards
Seniority
Principal, strategic leadership with hands-on technical execution
