Manufacturing Engineer II

Manufacturing Engineer will support the introduction of new products and manufacturing processes within a regulated medical device environment. The role focuses on equipment validation, process development, and ensuring manufacturing processes comply with regulatory and quality requirements. The engineer will work closely with cross-functional teams to support equipment qualification, process validation activities, and production line implementation.

Responsibilities:

• Design and develop manufacturing processes, procedures, and production layouts for assemblies, equipment installation, and material handling.
  
• Support new product introduction (NPI) activities including process development and validation.
  
• Execute equipment qualification activities (IQ/OQ/PQ) and support process validation lifecycle.
  
• Develop and execute validation protocols and reports for manufacturing equipment and processes.
  
• Support process characterization, operational qualification, and performance qualification activities.
  
• Develop and update Standard Operating Procedures (SOPs) and manufacturing documentation.
  
• Support change control processes in compliance with medical device regulations.
  
• Assist in statistical analysis and design of experiments (DOE) using tools such as Minitab.
  
• Provide line support during special builds and production activities.
  
• Investigate manufacturing issues, implement corrective actions, and ensure product quality.
  
• Collaborate with engineering teams to optimize manufacturing processes and equipment utilization.
  
• Ensure manufacturing processes comply with regulatory and quality system requirements.
  

*Other duties may be assigned*

Requirements

Minimum 3 to10 years of relevant engineering experience in manufacturing, validation, or process engineering within a regulated industry.

Bachelor’s Degree in Engineering completed.

Top 3 Candidate Experience Requirements:

1. Equipment Qualification (IQ) experience
   
2. OQ / PQ or Process Validation experience
   
3. Process Validation Lifecycle knowledge (Process Characterization → OQ → PQ)
   
4. DOE (preferred using Minitab)
   

Technical Skills (Must Have):

• Experience performing Equipment Qualification (IQ).
  
• Experience with Operational Qualification (OQ) and Performance Qualification (PQ).
  
• Knowledge of the Process Validation Lifecycle (process characterization → OQ → PQ).
  
• Experience supporting process validation within a regulated environment.
  

 Preferred Technical Skills:

• Experience with Design of Experiments (DOE) using Minitab.
  
• Experience with Injection Molding Processes.
  
• Experience in Process Development and Documentation.
  
• Experience with Equipment Validation.
  
• Experience supporting Special Builds and Manufacturing Line Support.
  

 Additional Skills:

• Computer System Validation (CSV)
  
• SOP Development
  
• Change Control in Medical Devices
  
• Experience with MES systems
  
• Documentation management within regulated industries