Mftg. Engineer II

The Manufacturing Engineer II is responsible for developing, implementing, and improving manufacturing processes, equipment, and methods to increase efficiency, yield, capacity, and product quality.

This role provides technical leadership for new and existing manufacturing processes including form-fill-seal packaging, automation implementation, coagulant dipping, and secondary operations, while supporting new product development, process validation, technology transfer, and cost reduction initiatives. 

The Manufacturing Engineer II serves as a key contributor on cross-functional teams, leading moderately complex projects, supporting capital investments, and applying Lean and Six Sigma methodologies within a regulated medical device manufacturing environment. 

Essential Duties and Responsibilities include the following (Other duties may be assigned):

Manufacturing Engineering & Process Development 


* Serve as the Manufacturing Engineering representative on product development projects, leading design for manufacturability (DFM), packaging selection, and manufacturing process definition. 



* Develop, optimize, and sustain manufacturing processes across form-fill-seal packaging, automation implementation, coagulant dipping, and secondary operations. 



* Analyze manufacturing processes to determine feasibility of in-house production versus outsourcing. 



* Develop cost estimates and support cost reduction initiatives through process optimization, automation, tooling improvements, and waste elimination. 



* Maintain technical ownership of assigned processes and equipment, including troubleshooting, continuous improvement, and performance monitoring. 

 

Process Optimization & Continuous Improvement 


* Identify and implement continuous improvement opportunities using Lean Manufacturing and Six Sigma tools. 



* Apply structured problem-solving methodologies to resolve complex manufacturing and quality issues. 



* Optimize process parameters, tooling designs, and equipment utilization to improve capacity, quality, and efficiency. 



* Support automation initiatives by evaluating, piloting, and implementing equipment upgrades, robotics, vision systems, and process controls. 

 

New Product Development & Technology Transfer 


* Collaborate with design, quality, sourcing, and project engineering teams to support successful new product launches. 



* Lead or support the development of robust manufacturing processes for new products, including pilot builds and scale-up activities. 



* Execute technology transfer activities for new and existing processes to internal manufacturing and qualified external suppliers. 

 

Validation, Qualification & Quality Systems 


* Coordinate and execute process validations and equipment qualifications (IQ/OQ/PQ) for new and existing manufacturing processes and equipment. 



* Generate, update, and maintain qualit...