Principal Manufacturing Engineer

Top Required Skills: Machine Vision Systems Expertise – Hands-on experience designing, implementing, developing, and optimizing automated vision inspection systems within manufacturing environments. Vision System Validation & Qualification – Leading IQ/OQ/PQ, process qualification, and validation of vision inspection systems in FDA- and ISO-regulated medical device manufacturing. Optical Measurement & Inspection Requirements – Defining system requirements, acceptance criteria, performance metrics, and inspection capabilities, with familiarity in GD&T and optical measurement principles. Troubleshooting & Manufacturing Process Optimization – Resolving complex vision system failures through root cause analysis and corrective actions while improving inspection capability, yield, throughput, and process efficiency.

Education Required: Bachelor’s Degree in Engineering Target Years of Experience: 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Duties: Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are following regulations.

Required Skills: Vision Systems Expertise: Serve as the primary technical expert for vision system design, implementation, validation, and optimization across manufacturing lines Lead the process development, qualification, and validation of vision inspection systems (IQ/OQ/PQ) in compliance with FDA and ISO regulations Define vision system requirements, acceptance criteria, and performance metrics in collaboration with R&D, Quality, and Contract Manufacturing partners Troubleshoot and resolve complex vision system failures, driving root cause analysis and implementing sustainable corrective actions Evaluate and recommend new vision system technologies to improve inspection capability, yield, and throughput Familiarity with GD&T and optical measurement principles

Preferred Skills: Experience with MES (Manufacturing Execution Systems) integration with vision systems Experience supporting Contract Manufacturers in a medical device environment Knowledge of machine learning or AI-based vision inspection technologies Six Sigma Green Belt or Black Belt certification. Microsoft Office, Minitab, Document Management Systems, MES, AutoCAD, Solid Works, SAP