Advanced Process Engineer
Core
Technical lead for manufacturing process development and automation within Third-Party Manufacturer (TPM) Operations, transitioning products from R&D to commercial production.
Role type
Senior IC process engineer (automation & manufacturing systems)
Builds
Automated manufacturing systems, validated processes, and scalable production solutions for medical devices
Domain
Healthcare / Medical Devices / Manufacturing Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
automation systems design, robotics integration, machine vision, process validation (IQ/OQ/PQ), statistical analysis, Python/SQL scripting, regulatory compliance (ISO 13485, 21 CFR Part 820), risk management (PFMEA, ISO 14971), project management
Preferred skills
Lean Manufacturing, Six Sigma, MES/QMS/ERP integration, third-party manufacturing partnerships
Technologies
Python, SQL, robotics, machine vision, MES, QMS, ERP
Responsibilities
Lead design and implementation of automated manufacturing systems; Develop and validate manufacturing processes from R&D to commercial scale; Manage vendor selection, FAT, SAT, installation, and commissioning; Execute IQ/OQ/PQ validation activities; Monitor manufacturing metrics and drive continuous improvement initiatives
Seniority
Senior, hands-on IC
